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 2019-05-23 for ATRICURE SYNERGY ABLATION SYSTEM OLL2 A000362 manufactured by Atricure, Inc..
[145928062]
(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 oll2 device was not reported or able to be subsequently ascertained. The complaint could not be confirmed.
Patient Sequence No: 1, Text Type: N, H10
[145928063]
It was reported on (b)(6) 2019 that a patient underwent a coronary artery bypass graft, ablation and left atrial appendage management procedure. The patient was on cardiopulmonary bypass, surgeon performed 3 times ablations on both pairs of pulmonary veins. The right inferior pulmonary vein ablations were done on bypass but not cross-clamped. The surgeon noted that he was high on atrial tissue, not vein tissue. He repositioned the clamp between each of the 3 ablations and used his fingers for blunt dissection around the pulmonary vein. No other instruments were used. It was noted that the tissue had a lot more fat on the superior portion. The surgeon used an atriclip ach135 for the left atrial appendage management and then the coronary artery bypass grafts were completed. The patient was taken off the cardiopulmonary bypass and that is when bleeding was noticed from two locations on the right inferior pulmonary vein. The patient was put back onto bypass and the area of bleeding was repaired with suturing. An hour after the patient left the operating room the patient was brought back to the operating room for bleeding. Patient was placed back on bypass, surgeon identified the source of bleeding and repaired. Post-surgery patient is recovering well. There were no reported device malfunctions. This was a procedural complication.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3011706110-2019-00028 |
| MDR Report Key | 8635784 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2019-05-23 |
| Date of Report | 2019-05-23 |
| Date of Event | 2019-04-23 |
| Date Mfgr Received | 2019-04-26 |
| Date Added to Maude | 2019-05-23 |
| 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 | ATRICURE SYNERGY ABLATION SYSTEM |
| Generic Name | ATRICURE SYNERGY ABLATION SYSTEM |
| Product Code | OCM |
| Date Received | 2019-05-23 |
| Model Number | OLL2 |
| Catalog Number | A000362 |
| 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. Life Threatening; 2. Required No Informationntervention | 2019-05-23 |