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 2018-03-09 for ATRICURE SYNERGY ABLATION SYSTEM OLL2 A000362 manufactured by Atricure, Inc..
[102072498]
(b)(4). The device was evaluated on 2/28/2017. The device evaluation indicated that the device met all specifications and functioned normally. There was no reported device malfunction.
Patient Sequence No: 1, Text Type: N, H10
[102072499]
On (b)(6) 2018, a (b)(6) male patient received an on-pump, tricuspid valve replacement via sternotomy including box lesion set ablation using an atricure synergy ablation system with oll2 clamp. The patient was heparinized for the procedure. It was reported that the patient was malnourished and appeared extremely small. During the procedure, the surgeon performed some manual digital dissection of the left pulmonary veins and placed the clamp on the left side. After a lapse of 10-15 minutes with no mention of damage or bleeding, the surgeon performed cryoablation with a cryoice cryoablation probe (cryo2) for the roof and floor line connecting lesions with two minutes of freeze time. The surgeon performed additional digital dissection to gain access to the floor line. After defrosting normally, the probe was removed from the chest. At that time, a hole was discovered in the left atrium near the base of the left atrial appendage. The surgeon sutured the perforation indicating that the hole was most likely burned into the tissue due to the patient? S decreased protein content. The surgeon decided not to place a clip on the laa. There was no reported transfusion required and no reported device malfunction. As of 2/13/2018, there was no reported negative outcomes per the charge nurse.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3011706110-2018-00135 |
| MDR Report Key | 7328834 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2018-03-09 |
| Date of Report | 2018-03-09 |
| Date of Event | 2018-02-08 |
| Date Mfgr Received | 2018-02-08 |
| Device Manufacturer Date | 2018-01-02 |
| Date Added to Maude | 2018-03-09 |
| 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 | 2018-03-09 |
| Returned To Mfg | 2018-02-21 |
| Model Number | OLL2 |
| Catalog Number | A000362 |
| Lot Number | 79867 |
| 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 | 2018-03-09 |