MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2009-08-31 for ULTRACINCH LP * UC-LP-8 manufactured by St. Jude Medical, Inc.
[1146608]
In trying to use the ultracinch for an ablation, the device did not pass the self check. Another device was opened and used to complete procedure. Manufacturer provided return good authorization (rga)# for product return evaluation.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1466571 |
| MDR Report Key | 1466571 |
| Date Received | 2009-08-31 |
| Date of Report | 2009-08-31 |
| Date of Event | 2009-08-25 |
| Report Date | 2009-08-31 |
| Date Reported to FDA | 2009-08-31 |
| Date Added to Maude | 2009-09-10 |
| 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 | 0 |
| 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 | ULTRACINCH LP |
| Generic Name | CATHETER, ABLATION, CARDIAC |
| Product Code | NTB |
| Date Received | 2009-08-31 |
| Returned To Mfg | 2009-08-31 |
| Model Number | * |
| Catalog Number | UC-LP-8 |
| Lot Number | 27409 |
| ID Number | * |
| Operator | NURSE |
| Device Availability | R |
| Device Age | 1 DY |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ST. JUDE MEDICAL, INC |
| Manufacturer Address | 14901 DEVEAU PLACE MINNETONKA MN 55345 US 55345 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2009-08-31 |