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 2018-06-08 for ATRICURE SYNERGY ABLATION SYSTEM OLL2 A000362-JP manufactured by Atricure, Inc..
[110455025]
(b)(4). The device was not returned for evaluation but a device history review was obtained for lot number 69151. There is nothing in the device history record that would indicate that the devices were released with any non-conformances that would contribute to the complaint.
Patient Sequence No: 1, Text Type: N, H10
[110455026]
It was reported on (b)(6) 2018 of an event from procedure on (b)(6) 2017, that a (b)(6) -year-old female patient underwent a maze procedure where an atricure oll2 was used. The surgeon ablated the right pulmonary vein and once completed, bleeding was observed from ablation line. The source of the bleeding was closed via suture. Post-op, the patient developed anemia and pleural effusion which was drained. Currently, the heart rate is back to normal sinus rhythm and the patient is doing fine. No device malfunction was reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3011706110-2018-00170 |
| MDR Report Key | 7581730 |
| Report Source | DISTRIBUTOR,FOREIGN,HEALTH PR |
| Date Received | 2018-06-08 |
| Date of Report | 2018-06-08 |
| Date of Event | 2017-09-06 |
| Date Mfgr Received | 2018-05-16 |
| Device Manufacturer Date | 2016-11-11 |
| Date Added to Maude | 2018-06-08 |
| 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 | ATRICURE SYNERGY ABLATION SYSTEM |
| Generic Name | ATRICURE SYNERGY ABLATION SYSTEM |
| Product Code | OCM |
| Date Received | 2018-06-08 |
| Model Number | OLL2 |
| Catalog Number | A000362-JP |
| Lot Number | 69151 |
| Device Expiration Date | 2019-10-01 |
| 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 | 2018-06-08 |