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 2017-01-31 for ATRICURE SYNERGY ABLATION SYSTEM OLL2 A000362 manufactured by Atricure Inc..
[66176042]
(b)(4) the device was returned for evaluation and visually and functionally tested pursuant to qrf-0305. C. The device met all criteria and functioned normally. The complaint could not be confirmed.
Patient Sequence No: 1, Text Type: N, H10
[66176043]
Mitral valve repair/replacement-maze-possibly tricuspid valve repair open sternotomy. During the maze procedure, the surgeon ablated the left pulmonary veins 6 times. Then, using their own pacing forceps, tested for isolation, it was noted veins were not isolated. He then ablated 6 more times and again was unable to gain isolation of the left pulmonary veins. At this time, when the surgeon lifted up the left side of the heart to look at the left pulmonary veins, he noticed a hole at one of his ablation lines on the pv. At this time he arrested the heart and completed the maze procedure. After completing the exclusion of the left atrial appendage and the connecting lesion to the superior left pulmonary vein, he then ablated the left pulmonary veins 2 more times. After completing the maze he then repaired the hole in the left pulmonary veins at the ablation line. Surgeon's complaint was that he felt that the clamp or algorithm of the asu was not working right. The same clamp was used for the entire case and good lesions were achieved on all other parts of the maze procedure. Over ablating the left pulmonary veins could have damaged tissue and caused the hole in the ablation line. Patient was on pump and heparinized. The case was delayed by ten to fifteen minutes. Surgeon completed maze, repaired hole in left pulmonary vein, completed mvr and tvr. Clamp was cleaned after every 6th ablation.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3003502395-2017-00020 |
| MDR Report Key | 6290301 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2017-01-31 |
| Date of Report | 2017-01-04 |
| Date of Event | 2017-01-04 |
| Date Mfgr Received | 2017-01-04 |
| Device Manufacturer Date | 2016-11-23 |
| Date Added to Maude | 2017-01-31 |
| 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 | MS. RANJANA IYER |
| Manufacturer Street | 7555 INNOVATION WAY |
| Manufacturer City | MASON OH 45040 |
| Manufacturer Country | US |
| Manufacturer Postal | 45040 |
| 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 | ISOLATOR SYNERGY SURGICAL ABLATION SYSTEM OPEN, LONG JAW |
| Product Code | OCM |
| Date Received | 2017-01-31 |
| Returned To Mfg | 2017-01-11 |
| Model Number | OLL2 |
| Catalog Number | A000362 |
| Lot Number | 69612 |
| Device Expiration Date | 2019-11-01 |
| Operator | PHYSICIAN |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| 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 | 2017-01-31 |