MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-09-07 for CONTURA BALLOON manufactured by Hologic, Inc..
[54057507]
Patient Sequence No: 1, Text Type: N, H10
[54057508]
Prior to insertion the balloon had a standard leak test by filling with saline and inspection for any visible leaks. None were seen at that time. The balloon was inserted and filled with 50cc's of saline (w/ contrast). This was on friday. We treated the patient the following monday, tuesday and the morning of wednesday (post insertion). We then performed a ct to reevaluate the balloon. After performing this ct (which we perform with all contura patients) we determined that the volume of the balloon had decreased by approximately 12cc. I contacted the company to find out what they suggest we do. They put me in contact with a consulting physicist. He talked me through a number of possibilities. He told me that we would want to contact the company after treatment if we determined that it was leaking/defective. We then replanned the plan for the smaller volume. This new plan was delivered for the afternoon of wednesday and the morning of thursday. For the afternoon treatment on thursday, we determined that more fluid had leaked based on the setup x-ray. An additional 10cc's were added to the balloon, after which we delivered the afternoon treatment (on thursday). The following morning of friday (7 days after insertion) we got a new ct scan. The balloon volume was 6cc less than the original plan (and therefore 6cc more than the ct on wednesday). The final two fractions were delivered on friday (7 days after insertion) and the balloon was removed. 4 days later, on tuesday, i filled the balloon with 50cc and wrapped it in paper towels. I determined when i examined it the next day, wednesday that the balloon was leaking from the area of the vacuum port on the opposite side of the balloon from the lumens. We're now ready to contact the company and inform them that the device was leaking, and they will inevitably send us bags/packages to ship the defective device back to them.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 5932087 |
| MDR Report Key | 5932087 |
| Date Received | 2016-09-07 |
| Date of Report | 2016-08-05 |
| Date of Event | 2016-07-27 |
| Report Date | 2016-08-05 |
| Date Reported to FDA | 2016-08-05 |
| Date Reported to Mfgr | 2016-08-05 |
| Date Added to Maude | 2016-09-07 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CONTURA BALLOON |
| Generic Name | SYSTEM, APPLICATOR, RADIONUCLIDE, REMOTE-CONTROLLED |
| Product Code | JAQ |
| Date Received | 2016-09-07 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | HOLOGIC, INC. |
| Manufacturer Address | 250 CAMPUS DRIVE MARLBOROUGH MA 01752 US 01752 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2016-09-07 |