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 2009-11-06 for ULTRACINCH DEPLOYABLE TISSUE ABLATION, UC-13 11481 manufactured by St. Jude Medical.
[1248317]
It was reported the device failed during the procedure, due to tissue adherence. "the device broke during movement to accommodate it". The device was replaced with another ultracinch 13 (reorder) and the procedure continued. The patient expired one week later, due to coagulopathy. The surgery was a reoperation and the surgeon was told that the procedure was not "indicated" in this case, but the procedure was performed anyway.
Patient Sequence No: 1, Text Type: D, B5
[8361611]
We are awaiting device return. A follow up report will be submitted once our investigation is complete. Date report submitted to fda manufacturer: 11/6/2009. Date the initial reporter provided the information to the manufacturer: 9/25/2009.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3003870001-2009-00014 |
| MDR Report Key | 1525514 |
| Report Source | 01,05,06,07 |
| Date Received | 2009-11-06 |
| Date of Report | 2009-09-25 |
| Date of Event | 2009-09-11 |
| Date Facility Aware | 2009-09-11 |
| Date Mfgr Received | 2009-11-03 |
| Date Added to Maude | 2009-11-16 |
| 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 | KAREN MCKELVEY |
| Manufacturer Street | ONE ST. JUDE MEDICAL DRIVE |
| Manufacturer City | ST. PAUL MN 55117 |
| Manufacturer Country | US |
| Manufacturer Postal | 55117 |
| Manufacturer Phone | 6517562000 |
| Manufacturer G1 | ST. JUDE MEDICAL |
| Manufacturer Street | 240 SANTA ANA COURT |
| Manufacturer City | SUNNYVALE CA 94085 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 94085 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ULTRACINCH DEPLOYABLE TISSUE ABLATION, UC-13 |
| Generic Name | ULTRACINCH, UC-13 |
| Product Code | NTB |
| Date Received | 2009-11-06 |
| Model Number | NA |
| Catalog Number | 11481 |
| Lot Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ST. JUDE MEDICAL |
| Manufacturer Address | SUNNYVALE CA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 2009-11-06 |