MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2015-01-28 for ATRICURE LUMITIP DISECTOR MID1 A000135 manufactured by Atricure, Inc..
[5185259]
During a procedure while on the left side attempting to bring the mid1 around the left pulmonary veins, the surgeon indicated he felt a pop. The mid light became visible thru the left atrial reflection at that time. Once the mid was around the pulmonary veins, bleeding was noticed and the blood pressure started dropping. The surgeon completed a sternotomy and placed the patient on by-pass. A hole in the right inferior pulmonary vein was noted and repaired. This was opposite the side he was working on. A 2nd smaller hole was noted on the dome and also repaired. No further ablation or appendage management was attempted. Patient was taken off by-pass and sternotomy closed.
Patient Sequence No: 1, Text Type: D, B5
[12795116]
(b)(4). The device was not retained by the facility. Device not returned for evaluation however device history record reviewed and no non-conformance or re-work noted during manufacturing process that would be related to the reported issue.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3003502395-2015-00007 |
| MDR Report Key | 4469186 |
| Report Source | 07 |
| Date Received | 2015-01-28 |
| Date of Report | 2014-12-29 |
| Date of Event | 2014-12-29 |
| Date Mfgr Received | 2014-12-29 |
| Date Added to Maude | 2015-02-02 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | JOHN HUFF |
| Manufacturer Street | 6217 CENTRE PARK DRIVE |
| Manufacturer City | WEST CHESTER OH 45069 |
| Manufacturer Country | US |
| Manufacturer Postal | 45069 |
| Manufacturer Phone | 5136444725 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ATRICURE LUMITIP DISECTOR |
| Generic Name | LAMP, SURGICAL |
| Product Code | GDI |
| Date Received | 2015-01-28 |
| Model Number | MID1 |
| Catalog Number | A000135 |
| Lot Number | 53142 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ATRICURE, INC. |
| Manufacturer Address | WEST CHESTER OH US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2015-01-28 |