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 2017-10-04 for ATRICURE SYNERGY ABLATION SYSTEM OLL2 A000362 manufactured by Atricure, Inc..
[88118844]
(b)(4) the device was returned for evaluation and visually and functionally tested. The device met all criteria and functioned normally.
Patient Sequence No: 1, Text Type: N, H10
[88118845]
On (b)(6) 2017, a (b)(6), male patient received a cabg/maze procedure via sternotomy and on-pump using an oll2 clamp and ablation system. While performing pulmonary vein isolation, the surgeon was getting transmural lesions on the right side and burned four (4) complete times. Once moving onto the other side, the surgeon positioned the clamp correctly on left veins and kept experiencing the clamp timing out and not getting a complete lesion. After four (4) attempts at ablating, the surgeon noticed bleeding and stated that the clamp had "tore the tissue on the veins". The bleeding was stopped with a stitch and a transfusion was not needed. The cabg procedure was completed, but the full bi-atrial maze procedure was not completed. The surgeon indicated that the bleeding was related to maneuvering around the difficult anatomy and that the tearing of the vein was a procedural complication based on a failure to remove the clamp prior to manipulation. The procedure was prolonged 6-7 minutes. No device malfunction was reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3011706110-2017-00087 |
| MDR Report Key | 6913378 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2017-10-04 |
| Date of Report | 2017-10-03 |
| Date of Event | 2017-09-07 |
| Date Mfgr Received | 2017-09-07 |
| Device Manufacturer Date | 2017-04-27 |
| Date Added to Maude | 2017-10-04 |
| 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 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 | 2017-10-04 |
| Returned To Mfg | 2017-09-28 |
| Model Number | OLL2 |
| Catalog Number | A000362 |
| Lot Number | 73383 |
| 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. Required No Informationntervention | 2017-10-04 |