MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,06,07 report with the FDA on 2008-02-04 for ULTRACINCH DEPLOYABLE TISSUE ABLATION UC-11 11479 manufactured by Epicor Medical, Inc..
[803574]
It was reported ablation was successful with the ultracinch device. The patient became unstable; however, after a couple minutes stabilized. The physician performed the ablation with an ultrawand device. The patient was then placed on the heart lung machine for the mitral reconstruction. Following that, the patient was removed from the heart lung machine and was in sinus rhythm. The patient then experienced an aortic dissection. Attempts to repair the dissection were unsuccessful and the patient expired. The ablation had already been completed and the device discarded when the patient developed the dissection. There has been no allegation that the ultracinch device caused the dissection.
Patient Sequence No: 1, Text Type: D, B5
[8046927]
The device was discarded at the hospital. The cause for the reported aortic dissection and subsequent death remain unknown. There has been no allegation that the ultracinch device caused the dissection / death.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3003870001-2008-00002 |
| MDR Report Key | 991164 |
| Report Source | 01,05,06,07 |
| Date Received | 2008-02-04 |
| Date of Report | 2008-02-05 |
| Date of Event | 2008-01-09 |
| Date Mfgr Received | 2008-01-09 |
| Device Manufacturer Date | 2006-02-17 |
| Date Added to Maude | 2008-02-08 |
| 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 | 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 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 | 2008-02-04 |
| Model Number | NA |
| Catalog Number | 11479 |
| Lot Number | NA |
| Device Expiration Date | 2009-02-28 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 960651 |
| Manufacturer | EPICOR MEDICAL, INC. |
| Manufacturer Address | SUNNYVALE CA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 2008-02-04 |