MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06,07 report with the FDA on 2011-03-25 for THERMACHOICE TC003 manufactured by Ethicon, Inc..
[16039953]
It was reported that a pt underwent an endometrial thermal ablation procedure on (b)(6) 2011. During the procedure, there was gradual pressure loss. The physician completed the procedure with pressure decreasing throughout the procedure. When the catheter was removed, the physician inserted fluid into the balloon to check for holes. A pin hole was identified where the balloon attaches to the catheter. A hysteroscopy was performed before and after the procedure and there were no adverse pt consequences.
Patient Sequence No: 1, Text Type: D, B5
[16095146]
Date sent to fda: 03/24/2011. (b)(4). Conclusion: the actual device involved in this event was returned for eval. The catheter was found to have a hole in the balloon. In addition, a review of the batch mfg records was conducted and the batch met all finished goods release criteria.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2210968-2011-00337 |
| MDR Report Key | 2066949 |
| Report Source | 05,06,07 |
| Date Received | 2011-03-25 |
| Date of Report | 2011-02-02 |
| Date of Event | 2011-02-22 |
| Date Facility Aware | 2011-02-22 |
| Report Date | 2011-02-22 |
| Date Mfgr Received | 2011-02-22 |
| Device Manufacturer Date | 2010-09-01 |
| Date Added to Maude | 2011-05-02 |
| 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 | 3 |
| Manufacturer Contact | DANIEL LAMONT |
| Manufacturer Street | ROUTE 22 WEST P.O. BOX 151 |
| Manufacturer City | SOMERVILLE NJ 088760151 |
| Manufacturer Country | US |
| Manufacturer Postal | 088760151 |
| Manufacturer Phone | 9082182708 |
| Manufacturer G1 | ETHICON, INC. - JUAREZ |
| Manufacturer Street | AVE DE LAS TORRES #7125 COL SALVARCAR |
| Manufacturer City | JUAREZ, CHIH 32580 |
| Manufacturer Country | MX |
| Manufacturer Postal Code | 32580 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | THERMACHOICE |
| Generic Name | CATHETER, BALLOON, TRANSCERVICAL |
| Product Code | MKN |
| Date Received | 2011-03-25 |
| Returned To Mfg | 2011-03-11 |
| Model Number | NA |
| Catalog Number | TC003 |
| Lot Number | CKMG14 |
| ID Number | NA |
| Device Expiration Date | 2012-09-30 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 5 MO |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ETHICON, INC. |
| Manufacturer Address | SOMERVILLE NJ 08876015 US 08876 0151 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-03-25 |