MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-04-27 for WOLF LUMITIP DISSECTOR MID1 A000195 manufactured by Atricure, Inc..
[73898428]
(b)(4). The device was returned for evaluation and visually and functionally tested pursuant to form-098. D. The device met all criteria and functioned normally. The complaint could not be confirmed.
Patient Sequence No: 1, Text Type: N, H10
[73898429]
During a bilateral vats ablation, the procedure had to convert to an open sternotomy to stop a bleed in the pulmonary artery. The patient had 4 previous catheter ablations and 1 failed lariat laa closure. It was noted that there were adhesions on the posterior wall of the left atrium. The right pulmonary vein dissection and ablation were completed without issue. The dome dissection and lesion on the left atrium were also completed without issue. The physician closed and proceeded to the left sided portion of the procedure and it was during dissection of the left pulmonary veins that he noticed that bleeding was occurring from an unknown location. The physician made the decision to open the chest to convert to full sternotomy to control the bleeding and upon evaluation, a small hole was noticed in the pulmonary artery. The physician closed the hole with suture and bleeding had stopped with minimal loss of blood and no transfusion needed. The left pulmonary vein isolation was completed without issue, and left atrial appendage removed with atriclip. Patients chest was closed in routine fashion and transferred to the icu in stable condition. The physician stated that during the routing of the lighted dissector he had snagged/ripped on adhesion or perforated the pa with the dissector.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3011706110-2017-00044 |
| MDR Report Key | 6527938 |
| Date Received | 2017-04-27 |
| Date of Report | 2017-04-06 |
| Date of Event | 2017-04-06 |
| Date Mfgr Received | 2017-04-06 |
| Device Manufacturer Date | 2016-09-15 |
| Date Added to Maude | 2017-04-27 |
| 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 |
| 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 | CINCINNATI OH 450400000 |
| Manufacturer Country | US |
| Manufacturer Postal | 450400000 |
| Manufacturer Phone | 5137555328 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | WOLF LUMITIP DISSECTOR |
| Generic Name | WOLF LUMITIP DISSECTOR |
| Product Code | GDI |
| Date Received | 2017-04-27 |
| Returned To Mfg | 2017-04-11 |
| Model Number | MID1 |
| Catalog Number | A000195 |
| Lot Number | 68324 |
| Device Expiration Date | 2019-09-01 |
| 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 CINCINNATI OH 450400000 US 450400000 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Life Threatening; 2. Required No Informationntervention | 2017-04-27 |