| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | ISOLATOR TRANSPOLAR PEN | ISOLATOR TRANSPOLAR PEN | ATRICURE, INC. | OCL | MAX1 | A000163 | UNKNOWN | N | N |
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2019-03-20 | 0 | 1. D |
Patient 1
CASE (B)(4) THE DEVICE WAS NOT RETURNED FOR EVALUATION AND A DEVICE HISTORY REVIEW WAS UNABLE TO BE COMPLETED AS THE RELEVANT LOT NUMBER FOR THE MAX1 DEVICE WAS NOT REPORTED OR ABLE TO BE SUBSEQUENTLY ASCERTAINED. THE COMPLAINT COULD NOT BE CONFIRMED.
Patient 1
IT WAS REPORTED THAT ON (B)(6) 2019 A MALE PATIENT UNDERWENT A BI-LATERAL MINI-THORACOTOMY MAZE WITH LAAX. THE SURGEON PERFORMED THE RIGHT PULMONARY VEIN ISOLATION VIA RIGHT MINI-THORACOTOMY WITHOUT INCIDENT AND CONFIRMED CONDUCTION BLOCK. SURGEON CLOSED THE RIGHT THORACOTOMY; THE OR STAFF REPOSITIONED THE PATIENT FOR THE LEFT-SIDED PART OF THE PROCEDURE. AT THE SAME TIME SURGEON NOTICED AN UNUSUAL RHYTHM ON THE OVERHEAD MONITORS. THE PATIENT WAS CARDIOVERTED AND ADMINISTERED AMNIODARONE. THE SURGEON PROCEEDED WITH THE REMAINDER OF THE MAZE PROCEDURE, MADE INCISION, WHILE PLACING THE SOFT-TISSUE RETRACTOR IN THE INTERCOSTAL SPACE, THE CIRCULATING NURSE ANNOUNCED THAT THE PATIENT HAD LOST ALL VITAL SIGNS. THE PATIENT WAS SHOCKED NUMEROUS TIMES TO NO AVAIL AND CPR WAS GIVEN. THE PATIENT WAS PUT ON EMERGENCY CARDIOPULMONARY PERFUSION AND THEY WERE ABLE TO GET A RHYTHM BACK. THE MAZE PROCEDURE WAS NOT COMPLETED. THE PATIENT EXPIRED ON (B)(6) 2019 AND IT WAS REPORTED THIS WAS LIKELY DUE TO A MYOCARDIAL INFARCTION. THIS EVENT IS A PROCEDURE RELATED COMPLICATION, THERE WAS NO REPORTED DEVICE MALFUNCTION.