MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2013-02-07 for THERMATRX CATHETER RX20035C manufactured by American Medical Systems, Inc..
[3332193]
It was reported that during a thermatrx treatment, the tmx catheter balloon burst about 3-4 minutes into procedure. The physician removed the 3. 5cm catheter and a new catheter was opened and used to complete the treatment without any further complaints. No injury was reported.
Patient Sequence No: 1, Text Type: D, B5
[10510933]
The catheter was returned and analyzed it appears that the catheter balloon developed a leak while inflated from an undetermined cause. The catheter was used for treatment after it's date of expiration. Should additional information become available regarding this event, it will be re-evaluated and a follow-up report will be sent.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2183959-2013-00602 |
| MDR Report Key | 2975488 |
| Report Source | 05 |
| Date Received | 2013-02-07 |
| Date of Report | 2013-01-08 |
| Date of Event | 2013-01-08 |
| Date Mfgr Received | 2013-01-08 |
| Device Manufacturer Date | 2009-09-01 |
| Date Added to Maude | 2013-04-22 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | SHARON ZURN, DIRECTOR |
| Manufacturer Street | 10700 BREN RD., WEST |
| Manufacturer City | MINNETONKA MN 55343 |
| Manufacturer Country | US |
| Manufacturer Postal | 55343 |
| Manufacturer Phone | 9529306347 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | THERMATRX CATHETER |
| Generic Name | THERMAL TREATMENT SYSTEM |
| Product Code | MEQ |
| Date Received | 2013-02-07 |
| Returned To Mfg | 2013-01-30 |
| Catalog Number | RX20035C |
| Device Expiration Date | 2012-09-11 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | AMERICAN MEDICAL SYSTEMS, INC. |
| Manufacturer Address | 10700 BREN RD., WEST MINNETONKA MN 55343 US 55343 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2013-02-07 |