MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2015-12-17 for ATRICURE SYNERGY ABLATION SYSTEM OLL2 A000362 manufactured by Atricure Inc..
[33824854]
The device was received and sent to atricure engineering for analysis. Upon inspection the device met all criteria and functioned normally. The end effector was inspected under magnification and nothing was noted that may have let to the reported incident. The complaint could not be confirmed.
Patient Sequence No: 1, Text Type: N, H10
[33824855]
It was reported that during a mvr/tvr/ maze procedure, while positioning the clamp to ablate the left pulmonary veins, the patient's atrium was inadvertently perforated. The surgeon had to patch and suture the hole, a cryo probe was used to complete the maze procedure,. The procedure was prolonged 25-30 minutes. The patient was off pump during the ablations, but was placed on by-pass pump when the surgeon discovered the perforation. The patient was heparinized, but amount is unknown. During a follow-up investigation on (b)(6) 2015, the surgeon stated that the patient is doing great and having no issues.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3003502395-2015-00048 |
| MDR Report Key | 5308194 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2015-12-17 |
| Date of Report | 2015-11-18 |
| Date of Event | 2015-11-18 |
| Date Mfgr Received | 2015-11-18 |
| Device Manufacturer Date | 2015-06-11 |
| Date Added to Maude | 2015-12-17 |
| 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 | MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. JOHN HUFF |
| Manufacturer Street | 6217 CENTRE PARK DRIVE |
| Manufacturer City | WEST CHESTER OH 450693886 |
| Manufacturer Country | US |
| Manufacturer Postal | 450693886 |
| Manufacturer Phone | 5136444725 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ATRICURE SYNERGY ABLATION SYSTEM |
| Generic Name | ISOLATOR SYNERGY CLAMP LONG JAW |
| Product Code | OCM |
| Date Received | 2015-12-17 |
| Returned To Mfg | 2015-12-02 |
| Model Number | OLL2 |
| Catalog Number | A000362 |
| Lot Number | 58411 |
| Device Expiration Date | 2018-05-01 |
| Operator | PHYSICIAN |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ATRICURE INC. |
| Manufacturer Address | 6217 CENTRE PARK DRIVE WEST CHESTER OH 450693886 US 450693886 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Life Threatening; 2. Required No Informationntervention | 2015-12-17 |