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 2009-09-02 for ULTRACINCH LP, 10 CELL, UC-LP-10 12545 NA manufactured by St. Jude Medical.
[17068068]
It was reported during a mvr and ablation procedure, an epicor ultracinch device was utilized and mitral valve was repaired. At the end of the procedure, the pt was off-pump but still cannulated, and a large hematoma was discovered on the pa. The pt was placed back on pump, and the hematoma was repaired. The pt is reportedly recovering. The surgeon was not certain of what caused the damage to the pa. A swan ganz catheter and tee echo probe were used.
Patient Sequence No: 1, Text Type: D, B5
[17315910]
The device was not returned for eval. However, review of the device history record confirmed this device met manufacturing requirements prior to shipment. Based on the info provided, the cause for the reported hematoma remains unk. Date report submitted to fda by manufacturer: 9/2/2009. Date the initial reporter provided the info to the manufacturer: 8/27/2009.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3003870001-2009-00009 |
| MDR Report Key | 1463549 |
| Report Source | 05,06,07 |
| Date Received | 2009-09-02 |
| Date of Report | 2009-08-27 |
| Date of Event | 2009-08-27 |
| Date Facility Aware | 2009-08-27 |
| Date Mfgr Received | 2009-08-28 |
| Device Manufacturer Date | 2008-05-30 |
| Date Added to Maude | 2009-09-09 |
| 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 | 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 | 2009-09-02 |
| Model Number | 12545 |
| Catalog Number | NA |
| Lot Number | NA |
| Device Expiration Date | 2013-05-30 |
| 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 | 2009-09-02 |