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 2007-08-08 for ULTRACINCH DEPLOYABLE TISSUE ABLATION DEVICE UNK manufactured by Epicor Medical, Inc..
[16373486]
Through a right thoracotomy approach for af ablation and robotic assisted mv repair, the physician stated that the pas device was advanced into place and the user experienced minor difficulty advancing the ultracinch device. During ablation, the device performed as expected. The physician experienced difficulties removing the ultracinch device from the pt. Following removal of the ultracinch device, the physician noticed blood coming from the wound. The physician electively performed a median sternotomy which revealed a tear in the laa just above the ablation line. The physician then sutured the tear with prolene suture which stopped the bleeding. The case was completed through the median sternotomy. There were no adverse complications to the pt, with exception of the sternotomy incision. There were no postop complications.
Patient Sequence No: 1, Text Type: D, B5
[16483990]
The device was not returned for analysis and review of the device history record was not possible as the serial number is unk. Based on the information provided to st jude medical, the cause for the reported perforation could not be determined.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3003870001-2007-00002 |
| MDR Report Key | 891107 |
| Report Source | 05,06,07 |
| Date Received | 2007-08-08 |
| Date of Report | 2007-08-08 |
| Date of Event | 2007-07-17 |
| Date Mfgr Received | 2007-07-18 |
| Date Added to Maude | 2007-08-14 |
| 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 DEVICE |
| Generic Name | ULTRACINCH DEPLOYABLE |
| Product Code | NTB |
| Date Received | 2007-08-08 |
| Model Number | NA |
| Catalog Number | UNK |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | NA |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 869778 |
| Manufacturer | EPICOR MEDICAL, INC. |
| Manufacturer Address | SUNNYVALE CA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2007-08-08 |