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 2007-06-11 for ULTRACINCH ACCESSORY KIT, UC-ACC-1 11486 manufactured by Epicor Medical, Inc..
[20160810]
It was reported during the procedure, the patient became hypotensive and his heart rate slowed down while the sizer-introducer was being introduced into the pericardial cavity. The sizer was removed and the intended ablation procedure was not completed. The ultracinch device was not used. There was no evidence of device-related injury. The patient was then paced through epicardial electrodes while the chest was closed, but the heart arrested again. An emergency thoracotomy was performed. The patient was given open chest cardiac massage with good hemodynamic response, but was unable to generate his own intrinsic pressure. The patient was then placed urgently under cardiopulmonary bypass but could not be resuscitated.
Patient Sequence No: 1, Text Type: D, B5
[20609589]
The device was not returned to sjm for analysis and review of the device history record was not possible, as the lot number is unknown. The operative notes states "the patients cause of death was hypotension and bradycardia as cardiac arrest. " it should be noted the physician stated there was no evidence of device related injury. Additionally, the surgery was a stand alone ablation for af with a minimally invasive right side approach. The instructions for use state that "the epicor device is intended for use in the ablation of cardiac tissue during cardiac surgery. "
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3003870001-2007-00001 |
| MDR Report Key | 862504 |
| Report Source | 05,06,07 |
| Date Received | 2007-06-11 |
| Date of Report | 2007-06-08 |
| Date of Event | 2007-03-30 |
| Date Mfgr Received | 2007-04-20 |
| Date Added to Maude | 2007-06-14 |
| 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 | PETER BLOMBERG |
| 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 ACCESSORY KIT, UC-ACC-1 |
| Generic Name | ULTRACINCH ACCESSORY KIT |
| Product Code | NTB |
| Date Received | 2007-06-11 |
| Model Number | NA |
| Catalog Number | 11486 |
| Lot Number | NA |
| ID Number | NA |
| 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 | 846915 |
| Manufacturer | EPICOR MEDICAL, INC. |
| Manufacturer Address | SUNNYVALE CA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 2007-06-11 |