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 2019-02-11 for ATRICURE SYNERGY ABLATION SYSTEM OLL2 A000362 manufactured by Atricure, Inc..
[135863027]
(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. This was a procedure related event. There was no report of any device malfunction.
Patient Sequence No: 1, Text Type: N, H10
[135863028]
It was reported that on (b)(6) 2019 a patient underwent a concomitant on-pump mitral valve repair and a left atrial ablation lesion set procedure. Patient was heparinized with an unknown amount. Surgeon used an oll2 and cryo2 device to perform the pulmonary vein isolation ablations. During procedure, the surgeon observed a clot in the left atrial appendage (laa) and a clot was also found in the left atrium. The clot was removed from the left atrium and laa and the laa was managed using a stapler. Post- procedure the patient experienced a stroke.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3011706110-2019-00009 |
| MDR Report Key | 8328706 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2019-02-11 |
| Date of Report | 2019-02-11 |
| Date Mfgr Received | 2019-01-16 |
| Date Added to Maude | 2019-02-11 |
| 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 | 2019-02-11 |
| Model Number | OLL2 |
| Catalog Number | A000362 |
| Lot Number | UNK |
| 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 | 2019-02-11 |