MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2014-10-22 for AMS THERMATRX TMX-3000 OFFICE THERMOTHERAPY manufactured by American Medical Systems (mn).
[5152928]
It was reported that two catheters had balloon leak issues during treatment. No patient complications were reported in relation to this event.
Patient Sequence No: 1, Text Type: D, B5
[12474409]
Additional information:catheter #1,catalog #: rx20020c. Catheter #2,catalog#: rx20025c.
Patient Sequence No: 1, Text Type: N, H10
[12482264]
Two thermatrx catheters were returned and analyzed. Catheter #1 performed within specifications and appeared normal. Catheter #2 had a pinhole size leak in the balloon that appeared to be the result of a sharp instrument. The balloon was not stretched or distorted, so it appears that the leak did not occur while the balloon was inflated. The connector at the end of one temperature sensor sleeve is missing. It is not known when this may have occurred.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2183959-2014-00470 |
| MDR Report Key | 4194826 |
| Report Source | 05 |
| Date Received | 2014-10-22 |
| Date of Report | 2014-10-08 |
| Date Mfgr Received | 2014-10-24 |
| Date Added to Maude | 2014-10-22 |
| 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 | MRS. SHARON ZURN |
| Manufacturer Street | 10700 BREN ROAD W |
| Manufacturer City | MINNETONKA MN 55343 |
| Manufacturer Country | US |
| Manufacturer Postal | 55343 |
| Manufacturer Phone | 9529306000 |
| Manufacturer G1 | AMERICAN MEDICAL SYSTEMS (MN) |
| Manufacturer Street | 10700 BREN ROAD W |
| Manufacturer City | MINNETONKA MN 55343 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 55343 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | AMS THERMATRX TMX-3000 OFFICE THERMOTHERAPY |
| Generic Name | SYSTEM, HYPERTHERMIA, RF/MICROWAVE (BPH), THERMOTHERAPY |
| Product Code | MEQ |
| Date Received | 2014-10-22 |
| Returned To Mfg | 2014-10-24 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | AMERICAN MEDICAL SYSTEMS (MN) |
| Manufacturer Address | 10700 BREN ROAD W MINNETONKA MN 55343 US 55343 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2014-10-22 |