Defective Suprapubic Catheter

[dnvrdave]

Sometimes (rarely), my suprapubic catheter stops draining for no apparent reason. It's not clogged -- it just stops draining completely.

I don't realize the problem until my bp goes up (180/95 to 210/110) and I start sweating. If I can get help, we change the catheter and the problem is solved. While waiting for help, I have tried draining the balloon, and sometimes the bladder then empties (or partially empties), but sometimes it doesn't.

Does anyone know what makes the catheter suddenly stop draining? My guess is that the balloon somehow blocks the flow by going inward, but maybe that's not possible. I have the last bad catheter and I will test it. It was in for only 3 days when it stopped draining. When we emptied the balloon, it filled a 32 oz leg bag with about 24 oz (with nitro paste, my bp was still 150/90).

The last time this happened was 2 years ago, and the catheter had been in for 3 weeks (I normally use them for 4 weeks). We drained the balloon that time, but no urine flowed. We also irrigated, but it didn't help either. Changing the catheter solved it.

Curiosity question: I've been c5/6 quad for 34 years. When I used to get ad (autonomic dysreflexia) from a "full" bladder, I would get a pounding headache (with bp not that high). But in the past few years, I don't get the headache, only sweating and tension. Does anyone know why? Do our bodies adapt as we age? Am I at less risk for stroke if there is no headache?

The catheter brand is Covidien (owned by Medtronic), silicone coated 24 fr, 5cc balloon. I've used this brand for years (tried many others) because it has been the most reliable. If the catheter is defective, what is the best way to prevent the problem in the future? What has been your experience contacting Medtronic (the manufacturer) or Edgepark (the supplier). It seems like someone should know about the problem because ad is so dangerous. That is why I'm posting here too.

[gjnl]

Sometimes (rarely), my suprapubic catheter stops draining for no apparent reason. It's not clogged -- it just stops draining completely.

I don't realize the problem until my bp goes up (180/95 to 210/110) and I start sweating. If I can get help, we change the catheter and the problem is solved. While waiting for help, I have tried draining the balloon, and sometimes the bladder then empties (or partially empties), but sometimes it doesn't.

Does anyone know what makes the catheter suddenly stop draining? My guess is that the balloon somehow blocks the flow by going inward, but maybe that's not possible. I have the last bad catheter and I will test it. It was in for only 3 days when it stopped draining. When we emptied the balloon, it filled a 32 oz leg bag with about 24 oz (with nitro paste, my bp was still 150/90).

The last time this happened was 2 years ago, and the catheter had been in for 3 weeks (I normally use them for 4 weeks). We drained the balloon that time, but no urine flowed. We also irrigated, but it didn't help either. Changing the catheter solved it.

Curiosity question: I've been c5/6 quad for 34 years. When I used to get ad (autonomic dysreflexia) from a "full" bladder, I would get a pounding headache (with bp not that high). But in the past few years, I don't get the headache, only sweating and tension. Does anyone know why? Do our bodies adapt as we age? Am I at less risk for stroke if there is no headache?

The catheter brand is Covidien (owned by Medtronic), silicone coated 24 fr, 5cc balloon. I've used this brand for years (tried many others) because it has been the most reliable. If the catheter is defective, what is the best way to prevent the problem in the future? What has been your experience contacting Medtronic (the manufacturer) or Edgepark (the supplier). It seems like someone should know about the problem because ad is so dangerous. That is why I'm posting here too.

I don't know for sure why you are having this problem, occasionally. I have read that the drainage eyelets of an indwelling catheter can become occluded when the urothelium (essentially the bladder wall lining) is sucked into the eyelets. Raising the urine drainage bag above the level of the bladder may release the vacuum that causes this problem. Possibly something similar may be happening when you deflate the catheter balloon and/or replace the catheter.

A vacuum can occur within the urine collection bag too. It is a good idea to leave a little bit of urine in the bag to keep the sides of the bag from sticking together and forming a vacuum which will stop the urine flow. Again, lifting the bag above the level of the bladder or disconnecting the drainage tubing from the catheter funnel may release the vacuum, and urine will start to flow again.

There is a catheter available that may solve these types of problems for you. It is called a Duette catheter by Poiesis. This catheter has two balloons and the drainage eyelets are positioned between the balloons. One balloon anchors the catheter in the bladder, the other balloon cushions the bladder wall and the drainage eyelets can't become occluded by the bladder wall tissue. Poiesis will send you free samples to try. Contact: charlene@poiesismedical.com and request the samples. The problem you are going to encounter is with the size of your catheter. A 24Fr catheter is a very large tubing. Duette catheters come in 14Fr, 16Fr, 18Fr and 20Fr. Since the supra pubic stoma will close quite quickly, you can size down to a 20Fr. I'd suggest using the catheter you have been using only in a size 22Fr for a month. Then try the Duette 20 Fr. Generally, it is best to use the smallest sized catheter that still allows proper drainage. I had a 16Fr placed in 2010 and still use the 16Fr. My urologist never sized the catheter up.

Usually the only manufacturing defect that will occur in an indwelling catheter is a problem with the balloon inflation/deflation ports.

[dnvrdave]

Here's an update: I tested the catheter and confirmed that it is defective. When the balloon is inflated, water does not flow through it. When the balloon is deflated, some water flowed (about 50%?), but after inflating and deflating the balloon again, the flow stopped completely, even with a deflated balloon.

My plan is to make a video of what I just described. And then I want to cut the tip off the catheter and look inside, to see what is blocking it. Hopefully, I will put the video on youtube describing this problem, since none seem to be there now.

I might also try to force water through the catheter with a syringe, to see if irrigation would help if the problem happens again. My fear is that water (sterile saline) would go in but not come back out, making the bladder pressure even higher.

I called Medtronic, and they will only deal with Edgepark Medical (where I bought the catheter). That seems hopeless. Both companies are too big to actually do something about this. The product says it was made in Malaysia. I would love to go there and see how indwelling catheters are made. Do they sterilize them after they are manufactured? Maybe it's the sterilization process that causes the defect. And by then it's too late to test them.

[SCI-Nurse]

I suggest you contact the company that made the catheter and distributor and also file a report with the FDA to see if you should complete the malfunctioning medical device. This can be serious with AD and they need to be aware.
CWO

[gjnl]

I called Medtronic, and they will only deal with Edgepark Medical (where I bought the catheter). That seems hopeless. Both companies are too big to actually do something about this. The product says it was made in Malaysia. I would love to go there and see how indwelling catheters are made. Do they sterilize them after they are manufactured? Maybe it's the sterilization process that causes the defect. And by then it's too late to test them.

When problems like this occur, you often times have to take your issue many steps higher than customer service representatives who field telephone calls. When you look at the leadership teams of companies, it is sometimes hard to know which executive vice president or senior vice president to write to with your complaint. Generally, I will send my first letter to the Chairman, Chief Executive Officer, and/or President of the company. Of course that person will never deal directly with the problem, but at least your letter has a better chance of finding its way to someone in the leadership chain whose department is responsible for the issue or product.

You've got a good start on a complaint letter in all that you have written here. Put something together in a letter format and send it to:

Omar Ishrak, Chairman and Chief Executive Officer
Medtronics
710 Medtronic Parkway
Minneapolis, MN 55432-5604

It will take some time, and of course there is a possibility that you may never hear anything back, but it is a 100% guarantee that you won't get any where trying to go through customer service call centers.

As for trying to go through Edgepark, you are absolutely assured that you won't get any where by talking to their customer service representatives. If you try to run this through Edgepark, you most certainly need to go straight to the top to get your letter passed on to someone who may have an executive roll in the company.

Steve Mason, President
Cardinal Health at Home
7000 Cardinal Place
Dublin, OH 43017

[dnvrdave]

Thank you gnjl, especially for the names and addresses!

[gjnl]

Thank you gnjl, especially for the names and addresses!

If you take this complaint route, keep us posted.

I don't want to dissuade you from making a YouTube video, but then make sure that goes the same route I've suggested. Making a YouTube video and just posting it probably won't go anywhere, unless you try to get it to the upper echelons of management.

[dnvrdave]

I don't want to dissuade you from making a YouTube video, but then make sure that goes the same route I've suggested. Making a YouTube video and just posting it probably won't go anywhere, unless you try to get it to the upper echelons of management.

Yes, my goal of course is prevention, quality control. I'm afraid this problem happens to other people, and the company rarely finds out. Ideally, every problem would get reported to them, at least every defect. If I make a video and include the Medtronic contact info, that seems like the best way to make a difference.

[gjnl]

Yes, my goal of course is prevention, quality control. I'm afraid this problem happens to other people, and the company rarely finds out. Ideally, every problem would get reported to them, at least every defect. If I make a video and include the Medtronic contact info, that seems like the best way to make a difference.

If you want other people to report their problems with defective catheters to Medtronic and you don't, the company may or may not find out about the problem. Most people won't take the time to write, seems you may be one of those too. Best case, make the video AND write Medtronic executive and include the link to the video as part of your complaint.

Another reason to write a letter to management is your experience with their customer service representative. Your experience with Medtronic customer service is just as concerning to me as your experience with a defective catheter. Customer service personnel need to be empowered to help solve a customers problem, not ignore them by pawning them off to the vendor. Management needs to authorize their customer service teams to provide replacement product, offer coupons for replacements, whatever it takes to satisfy a customers concern.

[dnvrdave]

... Best case, make the video AND write Medtronic executive and include the link to the video as part of your complaint.

Yes, my thinking exactly.

Your experience with Medtronic customer service is just as concerning to me as your experience with a defective catheter. Customer service personnel need to be empowered to help solve a customers problem, not ignore them by pawning them off to the vendor. Management needs to authorize their customer service teams to provide replacement product, offer coupons for replacements, whatever it takes to satisfy a customers concern.

Yes, I told the rep that Edgepark is "huge and won't do anything", and that the Bard rep handled my case well (re: defective leg bags), and why can't Medtronic do better? As you said, I have to take it to the top to make a difference. I will, as soon as my nurse has time to help me make a video.

[annev308]

Also, you can report adverse events directly to the FDA - https://www.accessdata.fda.gov/scripts/medwatch/ It has been my experience that manufacturers are fairly rapidly responsive to correspondence containing or referencing an event report.

[SCIfor55+yrs]

Report problems to the FDA:

`https://www.fda.gov/safety/reporting...us-problem-fda

[dnvrdave]

Great tips! I just made a video and submitted a report to the FDA. Next I will write to the CEOs of Medtronic and Edgepark and send them the report and a link to the video.

What I discovered is that there is a blockage at the top, where the insertion tube joins with the catheter, and it is slightly less blocked when the balloon is deflated.

https://www.youtube.com/watch?v=_dOHycZKgkE

[dnvrdave]

This is a little late, but I'm posting to let you know that the manufacturer is sometimes very responsive. It probably helped that I went through the FDA.

(11-18-2019) Response from the company, now Cardinal Health: (They said they have since fixed the problem.)

"The actual sample was dissected, a blister was found inside the funnel area. This blister would block the flow of urine through the drainage lumen inside the funnel area, thus causing the non-drainage issue reported by the customer."

[dnvrdave]

I have been using Dover Covidien (made by Cardinal Health) silicone coated 24fr foley catheters for many years, but I think there may be something wrong with them, at least this lot of 30 that I just bought. They are sending me a couple replacements, so I can try a different lot number.


If it’s not the catheter, maybe my bladder is just too sensitive or irritated after 31 years of indwelling catheters. I would consider using duettes, but they are not made as big as 24fr (would be too stiff, they say).


So what brand of foley suprapubic catheter do you use, and how reliable have they been.


I also started taking AZO and D-Mannose and it seems to be helping: AD sweating and headaches have stopped. But it could be because I put a different catheter in (expired in 2018, but it’s all I had).