MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2013-02-26 for THERMATRX CATHETER RX20025C manufactured by American Medical Systems, Inc..
[18847124]
It was reported that during a thermatrx treatment the tmx catheter balloon burst. The physician removed the 2. 5cm catheter and the treatment was completed using another 2. 5cm catheter. "there was no injury to the pt during this event. "
Patient Sequence No: 1, Text Type: D, B5
[19113638]
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 | 2183959-2013-00716 |
| MDR Report Key | 2999362 |
| Report Source | 05 |
| Date Received | 2013-02-26 |
| Date of Report | 2013-01-28 |
| Date of Event | 2013-01-17 |
| Date Mfgr Received | 2013-01-28 |
| Date Added to Maude | 2013-05-03 |
| 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 | 2013-02-26 |
| Returned To Mfg | 2013-02-08 |
| Catalog Number | RX20025C |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| 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 | 2013-02-26 |