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 2008-01-09 for ULTRACINCH DEPLOYABLE TISSUE ABLATION UC-11 11479 manufactured by Epicor Medical, Inc.
[776853]
During a mitral valve replacement/maze procedure, the pt was hemodynamically unstable throughout the entire case. The pt immediately went on bypass pump due to a severe medication-related allergic reaction which caused hemodynamic changes. Throughout the procedure, the pt's abdomen became increasingly distended. Subsequent drainage from the abdomen yielded many cc's of clear fluid. A medtronic tissue valve was implanted in the mitral position. The pt was in chronic af in which the physician wished to treat. The pt subsequently came off bypass pump and heart chambers completely filled. The left atrium was sized and a ultracinch device was used. With approximately 2 minutes remaining in a 9 min algorythm, the physician instructed the ablation unit be stopped. The ultracinch device was removed and the pt began to bleed into the chest cavity. The pt was placed back on the bypass pump and the physician began to suture the left atrium. The pt continued to bleed into chest cavity and the pt expired several hours later.
Patient Sequence No: 1, Text Type: D, B5
[8038298]
St jude medical is attempting to obtain add'l info regarding this event. A follow-up report will be submitted upon completion of our investigation.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3003870001-2008-00001 |
| MDR Report Key | 977233 |
| Report Source | 05,06,07 |
| Date Received | 2008-01-09 |
| Date of Report | 2008-01-09 |
| Date of Event | 2007-12-12 |
| Date Mfgr Received | 2007-12-12 |
| Date Added to Maude | 2008-01-11 |
| 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 | 3 |
| Event Location | 0 |
| Manufacturer Contact | JOHN RISSE |
| 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 CT. |
| 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 | 2008-01-09 |
| Model Number | NA |
| Catalog Number | 11479 |
| Lot Number | NA |
| ID Number | * |
| Device Expiration Date | 2008-11-28 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 945279 |
| Manufacturer | EPICOR MEDICAL, INC |
| Manufacturer Address | * SUNNYVALE CA * US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 2008-01-09 |