MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2012-06-04 for THERMACHOICE III * manufactured by Ethicon.
[2726300]
Unable to get ablation machine to hold pressure during procedure. One probe had a leak in it. Case aborted. ======================manufacturer response for thermal balloon ablation system, thermachoice 2 (per site reporter). ======================manufacturer sent four kits to send the contaminated catheters back for inspection and possible credit. Catheter sales rep had been here a month ago for same issue, could be related to training.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2615948 |
| MDR Report Key | 2615948 |
| Date Received | 2012-06-04 |
| Date of Report | 2012-06-04 |
| Report Date | 2012-06-04 |
| Date Reported to FDA | 2012-06-04 |
| Date Added to Maude | 2012-06-14 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | THERMACHOICE III |
| Generic Name | THERMAL BALLOON ABLATION SYSTEM |
| Product Code | MKN |
| Date Received | 2012-06-04 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | PHYSICIAN |
| Device Availability | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ETHICON |
| Manufacturer Address | ROUTE 22 WEST SOMERVILLE NJ 08876 US 08876 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-06-04 |