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 2008-06-12 for ULTRACINCH DEPLOYABLE TISSUE ABLATION , UC-8 11476 NA manufactured by Epicor Medical Inc..
[861473]
The pt has chronic atrial fibrillation and was scheduled for a mitral valve repair/replace along with a triple coronary artery bypass graft procedure. The physician created a smaller than normal initial incision when performing the sternotomy due to the pt's age. This led to some difficulty in performing the procedure later on. The pt started to fibrillate initially when the introducer was cinched around the upper atrium and had to be defibrillated once when the device was being sized. Once the device was sized, the surgeon had some trouble getting it in place, and had to put the pt on partial bypass to take out some heart volume and create space for the cinch to pass behind the heart. This took some time and the device was in place and gravity fed from the saline bag for at least 30 mins. Once the device was finally in place and the ablation began, the pt started to fibrillate almost immediately (during stage 1). The ablation control sys was then paused while the pt was once again defibrillated and then we were able to resume the ablation cycle. The ablation cycle was then completed without any errors or warnings, or the pt going into another bout of fibrillations. During the course of the rest of the procedure, a st. Jude ring was also used to repair the mitral valve. The pt experienced a spinal infarction. When the pt regained consciousness (woke up), she could not move from the chest down. The anesthesiologist commented that this procedure, especially the sizing of the device, was very "rough" on the pt due to the restriction of the upper atrium, which was evident by the pt's reactions during the sizing procedure. This was the 2nd case for the physician. St. Jude medical was notified on june 10, 2008 that the pt expired. Currently, we have no info indicating the death was due to our device.
Patient Sequence No: 1, Text Type: D, B5
[8016841]
The device was not returned for analysis. However, review of the device history record confirmed this lot met mfg requirements prior to shipment. The cause for the reported spinal infarction, paralysis and pt death remains unk. Should add'l info become available regarding the pt death, a f/u report will be submitted. The ultracinch ablation device instructions for use warns not to use for cardiac ablation on pts who are on cardiopulmonary bypass.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3003870001-2008-00003 |
| MDR Report Key | 1059136 |
| Report Source | 05,06,07 |
| Date Received | 2008-06-12 |
| Date of Report | 2008-06-11 |
| Date of Event | 2008-05-12 |
| Date Facility Aware | 2008-05-12 |
| Date Mfgr Received | 2008-05-15 |
| Device Manufacturer Date | 2007-07-12 |
| Date Added to Maude | 2008-06-17 |
| 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 | JOHN RISSE |
| Manufacturer Street | 14901 DEVEAU PL |
| 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-8 |
| Generic Name | ULTRACINCH, UC-8 |
| Product Code | NTB |
| Date Received | 2008-06-12 |
| Model Number | 11476 |
| Catalog Number | NA |
| Lot Number | NA |
| Device Expiration Date | 2010-07-12 |
| 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 | 1027439 |
| Manufacturer | EPICOR MEDICAL INC. |
| Manufacturer Address | SUNNYVALE CA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 2008-06-12 |