MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2016-09-21 for ATRICURE SYNERGY ABLATION SYSTEM OLL2 A000362 manufactured by Atricure, Inc..
[55315078]
Complaint # (b)(4). The device was not returned for evaluation, however, the dev ice history record was reviewed and no non-conformance or reworks were noted during the manufacturing process that relate to the reported issue. Device was discarded by account.
Patient Sequence No: 1, Text Type: N, H10
[55315079]
It was reported during avr and pvi procedure, during right pulmonary vein isolation transmurality was not achieved for 3 times and the conductance-line in display did not move for over 40 seconds, ablation lines were made. At this time, no error code was displayed. For the left pvi transmurality was achieved the second time. The operation was completed, then the bleeding was noticed from postoperative drain. A re-thoracotomy was conducted. The bleeding part was suspected the position from pvi, but not from it.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3003502395-2016-00123 |
| MDR Report Key | 5968312 |
| Report Source | DISTRIBUTOR |
| Date Received | 2016-09-21 |
| Date of Report | 2016-08-24 |
| Date of Event | 2016-08-02 |
| Date Mfgr Received | 2016-08-24 |
| Date Added to Maude | 2016-09-21 |
| 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 | MRS. RANJANA IYER |
| Manufacturer Street | 7555 INNOVATION WAY |
| Manufacturer City | MASON OH 450403886 |
| Manufacturer Country | US |
| Manufacturer Postal | 450403886 |
| Manufacturer Phone | 5137555328 |
| 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 | 2016-09-21 |
| Model Number | OLL2 |
| Catalog Number | A000362 |
| Lot Number | 61640 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ATRICURE, INC. |
| Manufacturer Address | 7555 INNOVATION WAY MASON OH 450403886 US 450403886 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Life Threatening; 2. Required No Informationntervention | 2016-09-21 |