MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,foreign,health pr report with the FDA on 2018-04-27 for ISOLATOR SYNERGY SURGICAL ABLATION SYSTEM OPEN, LONG JAW OLL2 A000362-JP manufactured by Atricure, Inc..
[106836854]
(b)(4). The product 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.
Patient Sequence No: 1, Text Type: N, H10
[106836855]
A patient underwent a surgical procedure where the surgeon was using a oll2 clamp to ablate the left pv for pvi, the surgeon tried to guide the clamp from the inferior left pv rather than from the superior pv. However, when guiding the clamp, the lower jaw of the clamp accidently hit the laa, and bleeding was observed from the puncture site of the laa. The patient was on pump when the incident occurred, so the surgeon cross clamped the aorta. The puncture site was closed with sutures and the procedure was continued with the oll2 and there were no further issues.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3011706110-2018-00149 |
| MDR Report Key | 7470591 |
| Report Source | DISTRIBUTOR,FOREIGN,HEALTH PR |
| Date Received | 2018-04-27 |
| Date of Report | 2018-04-27 |
| Date Mfgr Received | 2018-04-04 |
| Device Manufacturer Date | 2017-09-19 |
| Date Added to Maude | 2018-04-27 |
| 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 Street | 7555 INNOVATION WAY |
| Manufacturer City | MASON OH 45040 |
| Manufacturer Country | US |
| Manufacturer Postal | 45040 |
| 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 | ISOLATOR SYNERGY SURGICAL ABLATION SYSTEM OPEN, LONG JAW |
| Generic Name | ISOLATOR SYNERGY SURGICAL ABLATION SYSTEM OPEN, LONG JAW |
| Product Code | OCM |
| Date Received | 2018-04-27 |
| Model Number | OLL2 |
| Catalog Number | A000362-JP |
| Lot Number | 76675 |
| Operator | OTHER HEALTH CARE 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 | 2018-04-27 |