MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,06,07 report with the FDA on 2012-06-27 for THERMACHOICE TC033 manufactured by Ethicon, Inc..
[2683166]
It was reported that a pt underwent an endometrial thermal ablation procedure on (b)(6) 2012. The procedure was aborted before the therapy cycle started. During titration, the pressures stabilized to 175-180mmhg. During the heating cycle, pressures dropped to 110mmhg and at 4 mins, the generator stopped. The balloon was examined and was intact. Since the pressure drop was not sudden, the physician concluded that it was a floppy uterus and inserted the catheter. The pressure would not go higher than 100mmhg. A laparoscopy was done and showed a small perforation at the fundus of the uterus and no bowel injury. An abdominal hysterectomy was done which was not solely due to the ruptured uterus and was discussed with the pt prior to the procedure. The physician opined that the perforation was caused by a weak and thin myometrium, which worsened with pressure titration and eventually tore. Initially, the current condition of the pt was reported as fine and happy. However, additional info received stated that the pt underwent a colostomy and is currently in icu.
Patient Sequence No: 1, Text Type: D, B5
[10093592]
(b)(4). Conclusion: no conclusion can be drawn at this time. Should additional info be obtained, a supplemental 3500a form will be submitted accordingly. 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 | 2210968-2012-02363 |
| MDR Report Key | 2649875 |
| Report Source | 01,05,06,07 |
| Date Received | 2012-06-27 |
| Date of Report | 2012-06-04 |
| Date of Event | 2012-06-04 |
| Date Facility Aware | 2012-06-04 |
| Report Date | 2012-06-04 |
| Date Mfgr Received | 2012-06-04 |
| Device Manufacturer Date | 2011-08-01 |
| Date Added to Maude | 2012-07-12 |
| 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 | 3 |
| 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 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 | 2012-06-27 |
| Model Number | NA |
| Catalog Number | TC033 |
| Lot Number | DJMG01 |
| ID Number | NA |
| Device Expiration Date | 2013-08-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | 9 MO |
| Device Eval'ed by Mfgr | R |
| 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 | 1. Required No Informationntervention | 2012-06-27 |