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 2018-05-10 for ATRICURE SYNERGY ABLATION SYSTEM OSL2 A000432 manufactured by Atricure, Inc..
[107870670]
(b)(4). The device was returned and visually and functionally tested. The device met all criteria and functioned normally. The complaint could not be confirmed. There was no report of any device malfunctions.
Patient Sequence No: 1, Text Type: N, H10
[107870671]
On (b)(6) 2018 a (b)(6) female patient underwent a on-pump avr/pvi/ascending procedure. The surgeon used an osl2 and performed 4 ablations and cleaned the clamp in between each ablation. At the end of the ablations, the surgeon found a hole near where the clamp had been used near the left pv at the end of the case. There was bleeding that was controlled by suture but did not necessitate a transfusion. Patient was fully heparinized and the procedure was prolonged 20 minutes. Post- procedure patient outcome was good.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3011706110-2018-00161 |
| MDR Report Key | 7503022 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2018-05-10 |
| Date of Report | 2018-05-10 |
| Date of Event | 2018-04-17 |
| Date Mfgr Received | 2018-04-18 |
| Device Manufacturer Date | 2016-09-02 |
| Date Added to Maude | 2018-05-10 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | ANUPAM BEDI |
| Manufacturer Street | 7555 INNOVATION WAY |
| Manufacturer City | MASON OH 45040 |
| Manufacturer Country | US |
| Manufacturer Postal | 45040 |
| 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 | ATRICURE SYNERGY ABLATION SYSTEM |
| Generic Name | ATRICURE SYNERGY ABLATION SYSTEM |
| Product Code | OCM |
| Date Received | 2018-05-10 |
| Returned To Mfg | 2018-05-01 |
| Model Number | OSL2 |
| Catalog Number | A000432 |
| Lot Number | 67706 |
| Device Expiration Date | 2018-08-01 |
| Operator | OTHER HEALTH CARE PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | R |
| 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. Life Threatening; 2. Required No Informationntervention | 2018-05-10 |