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 2009-11-20 for ULTRACINCH LP, 10 CELL, UC-LP-10 12545 manufactured by St. Jude Medical.
[1251368]
It was reported a routine ablation was completed, and the patient immediately went on pump to do the primary surgery. The patient came off pump after the conclusion of the case, and was taken to the recovery room. In the recovery room, the staff noticed the patient was bleeding. The patient was transferred to the operating room where 1 or 2 thin areas in the back of the heart and a small opening / tear were repaired. The patient was taken back to the operating room again. The patient is doing fine and is back in sinus rhythm. The st. Jude medical representative stated the surgeon agreed to have a surgeon, who is a trainer join him on his next epicor procedure to see if he could offer any suggestions. The st. Jude medical representative was at the acs the entire time and did not see any error messages.
Patient Sequence No: 1, Text Type: D, B5
[8506249]
The device was not returned for evaluation. However, review of the device history record confirmed the device met manufacturing requirements prior to shipment. The cause for the reported bleeding and subsequent surgeries could not be determined. The user agreed to have a surgeon, who is a trainer join him on his next epicor procedure to see if he could offer any suggestions.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3003870001-2009-00016 |
| MDR Report Key | 1543759 |
| Report Source | 05,06,07 |
| Date Received | 2009-11-20 |
| Date of Report | 2009-11-10 |
| Date of Event | 2009-11-10 |
| Date Facility Aware | 2009-11-10 |
| Date Mfgr Received | 2009-11-12 |
| Device Manufacturer Date | 2009-07-31 |
| Date Added to Maude | 2009-11-27 |
| 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 LP, 10 CELL, UC-LP-10 |
| Generic Name | ULTRACINCH LP, 10 CELL |
| Product Code | NTB |
| Date Received | 2009-11-20 |
| Model Number | NA |
| Catalog Number | 12545 |
| Lot Number | NA |
| Device Expiration Date | 2010-07-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| 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. Other | 2009-11-20 |