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 2009-04-21 for ULTRACINCH DEPLOYABLE TISSUE ABLATION UC-11 11479 manufactured by St. Jude Medical.
[1145286]
The physician placed an epicor ultracinch device around the left atrium. Halfway through the ablation, the patient's pressure dropped and arterial blood was observed flowing from an area near the left atrial appendage. Ablation was continued and the surgeon repaired the area of blood leak with two sutures.
Patient Sequence No: 1, Text Type: D, B5
[8328251]
The device was not returned for analysis. The cause for the reported drop in blood pressure and bleeding remains unknown.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3003870001-2009-00002 |
| MDR Report Key | 1367407 |
| Report Source | 05,06,07 |
| Date Received | 2009-04-21 |
| Date of Report | 2009-04-21 |
| Date of Event | 2009-04-07 |
| Date Facility Aware | 2009-04-07 |
| Date Mfgr Received | 2009-04-09 |
| Device Manufacturer Date | 2008-01-25 |
| Date Added to Maude | 2009-04-27 |
| 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 | PHYLLIS PIET-HUGHES |
| Manufacturer Street | 14901 DEVEAU PLACE |
| Manufacturer City | MINNETONKA MN 55345 |
| Manufacturer Country | US |
| Manufacturer Postal | 55345 |
| Manufacturer Phone | 9529334700 |
| 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-11 |
| Generic Name | ULTRACINCH, UC-11 |
| Product Code | NTB |
| Date Received | 2009-04-21 |
| Model Number | NA |
| Catalog Number | 11479 |
| Lot Number | NA |
| Device Expiration Date | 2011-01-25 |
| 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 | 2009-04-21 |