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 2008-10-09 for ULTRACINCH ACCESSORY KIT, UC-ACC-1 11486 manufactured by Epicor Medical, Inc..
[946497]
It was reported the sizing tool pulled apart from the ultracinch device. The sizer broke, leaving the ultracinch device dislodged on the back side of the heart. The ultracinch device was pulled thru with a clamp with no intervention required. There were no consequences to the patient.
Patient Sequence No: 1, Text Type: D, B5
[8098667]
We are awaiting device return. Once the evaluation has been completed, a follow-up medwatch report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3003870001-2008-00005 |
| MDR Report Key | 1195972 |
| Report Source | 05,06,07 |
| Date Received | 2008-10-09 |
| Date of Report | 2008-10-09 |
| Date of Event | 2008-09-16 |
| Date Facility Aware | 2008-09-16 |
| Date Mfgr Received | 2008-09-16 |
| Date Added to Maude | 2009-10-20 |
| 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 | PHYLLIS PIET-HUGHES |
| Manufacturer Street | 14901 DEVEAU PLACE |
| Manufacturer City | MINNETONKA MN 55345 |
| Manufacturer Country | US |
| Manufacturer Postal | 55345 |
| Manufacturer Phone | 9529334700 |
| Manufacturer G1 | EPICOR MEDICAL, INC. |
| 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 ACCESSORY KIT, UC-ACC-1 |
| Generic Name | ULTRACINCH ACCESSORY KIT |
| Product Code | NTB |
| Date Received | 2008-10-09 |
| Model Number | NA |
| Catalog Number | 11486 |
| Lot Number | NA |
| ID 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 | EPICOR MEDICAL, INC. |
| Manufacturer Address | SUNNYVALE CA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2008-10-09 |