MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2019-03-20 for ISOLATOR TRANSPOLAR PEN MAX1 A000163 manufactured by Atricure, Inc..
[139352247]
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 Sequence No: 1, Text Type: N, H10
[139352248]
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.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3011706110-2019-00012 |
| MDR Report Key | 8437317 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2019-03-20 |
| Date of Report | 2019-03-20 |
| Date of Event | 2019-02-19 |
| Date Mfgr Received | 2019-02-19 |
| Date Added to Maude | 2019-03-20 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. JOHN EHLERT |
| Manufacturer Street | 7555 INNOVATION WAY |
| Manufacturer City | MASON OH 45040 |
| Manufacturer Country | US |
| Manufacturer Postal | 45040 |
| Manufacturer Phone | 5137554563 |
| Manufacturer G1 | ATRICURE, INC. |
| Manufacturer Street | 7555 INNOVATION WAY |
| Manufacturer City | MASON OH 45040 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 45040 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ISOLATOR TRANSPOLAR PEN |
| Generic Name | ISOLATOR TRANSPOLAR PEN |
| Product Code | OCL |
| Date Received | 2019-03-20 |
| Model Number | MAX1 |
| Catalog Number | A000163 |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ATRICURE, INC. |
| Manufacturer Address | 7555 INNOVATION WAY MASON OH 45040 US 45040 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 2019-03-20 |