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 2019-03-25 for ATRICURE SYNERGY ABLATION SYSTEM OLL2 A000362 manufactured by Atricure, Inc..
[139695580]
Case-(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
[139695581]
It was reported by the surgeon that during one of his surgical procedures while ablating the junction where pulmonary vein meets the roof and/or the floor lesions when some bleeding was observed bleeding that may be been attributed to over burning from the oll2 device. Surgeon is theorizing that the point where lesions overlap the tissue may have? Broken down? And bled. Surgeon used a pledgetted suture to close the defect and the patient did well. This event is a procedure related complication, there was no reported device malfunction.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3011706110-2019-00014 |
| MDR Report Key | 8447957 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2019-03-25 |
| Date of Report | 2019-03-25 |
| Date Mfgr Received | 2019-02-25 |
| Date Added to Maude | 2019-03-25 |
| 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 | 2019-03-25 |
| 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 | 2019-03-25 |