MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2016-07-15 for ATRICURE SYNERGY ABLATION SYSTEM OLL2 A000362 manufactured by Atricure, Inc..
[49631863]
(b)(4) the device was not returned for evaluation, however, the device history record was reviewed and no non-conformance or reworks were noted during the manufacturing process that relate to the reported issue. Device discarded by facility.
Patient Sequence No: 1, Text Type: N, H10
[49631864]
It was reported that during mvr, tap and maze, on-pump and beating, the first lpvi was not able to get transmurality and conducting stopped in 40 seconds. On the same position, conducting again, could not get transmurality in 20 seconds. Therefore, the conducting position was moved a little, the conducting was completed in 20 seconds at this time. The clamp was released and removed, bleeding was observed. The bleeding position was at lipv side on pvi line, sized 2cm. Although suturing from out, patient's tissue was ruptured. Therefore, biological adhesive-sheet and hemostatic material was applied. Also, cutting in left atria and did mattress suture from inside. They stopped the bleeding. The surgeon commented that the operation procedure was as usual and there was no tension in ablation part. After the operation, the patient is recovering without any issue at this time.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3003502395-2016-00061 |
| MDR Report Key | 5797823 |
| Report Source | DISTRIBUTOR |
| Date Received | 2016-07-15 |
| Date of Report | 2016-06-24 |
| Date of Event | 2016-06-03 |
| Date Mfgr Received | 2016-06-24 |
| Date Added to Maude | 2016-07-15 |
| 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 | 6217 CENTRE PARK DRIVE |
| Manufacturer City | WEST CHESTER OH 450693886 |
| Manufacturer Country | US |
| Manufacturer Postal | 450693886 |
| Manufacturer Phone | 5137555320 |
| 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 | 2016-07-15 |
| Model Number | OLL2 |
| Catalog Number | A000362 |
| Lot Number | 60646 |
| 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 | 6217 CENTRE PARK DRIVE WEST CHESTER OH 450693886 US 450693886 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Life Threatening; 2. Required No Informationntervention | 2016-07-15 |