MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2015-11-13 for WOLF LUMPITIP DISSECTOR MID1 A000195 manufactured by Atricure, Inc..
[31178706]
During a conversation between the surgeon and the regional sales manager, the surgeon said he encountered a tissue tear in the pulmonary vein using the dissector, there was no device defect or malfunction, and the surgeon firmly believes he would have torn the tissue with whatever was in his hands do the patient's condition. The bleeding was controlled, the surgeon then arrested the heart to do the rest of the concomitant procedure. Upon coming off pump he said the patient was pretty sick and expired for a multitude of reasons and complications. " the regional sales manager review the device at the time of the incident and found defects or malfunctions. The device was not returned for evaluation, it was discarded after use. Since the device was returned, a device history record review was conducted. There was no non-conformances or reworks noted during the manufacturing process that relate to the reported issue. Device discarded by facility.
Patient Sequence No: 1, Text Type: N, H10
[31178707]
It was reported that during a cabg maze, after taking the ima, the surgeon cannulated to get the patient on pump. We did the testing both gps and entrance block testing after he dissected to get to the pulmonary veins. He did his pvi first on the right side and then we did entrance block testing again. Once he was done with the pvi and testing on right side, he noticed what he thought was a hole/nick in the pulmonary veins. The surgeon repaired the pulmonary vein to stop the bleeding. The surgeon believes the hole/nick was due to the patient's condition, however to ensure no device defect, the rep. Checked the lighted dissector to make sure there was nothing there to cause a tear. The rep confirmed that there was nothing wrong with the dissector device. After the surgeon repaired the pulmonary vein on the right side, he moved to the left pulmonary veins to do entrance block testing and gps and to do the pvi. Afterwards, the surgeon opened the left atrium and performed the left sided lesion set. He then did his cabg x3. Once he was finished with the cabg, he started rewarming. Surgeon then opened the right atrium and completed the right sided lesion set for the maze. No more was mentioned about the pulmonary vein issue on the right and everything was successfully completed with the maze. Upon coming off pump the surgeon said the patient was pretty sick and expired for a multitude of reasons and complications.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3003502395-2015-00041 |
| MDR Report Key | 5223616 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2015-11-13 |
| Date of Report | 2015-10-19 |
| Date of Event | 2015-10-09 |
| Date Mfgr Received | 2015-10-19 |
| Device Manufacturer Date | 2014-08-01 |
| Date Added to Maude | 2015-11-13 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 0 |
| Reprocessed and Reused Flag | 3 |
| 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 DR. |
| Manufacturer City | WEST CHESTER OH 450693886 |
| Manufacturer Country | US |
| Manufacturer Postal | 450693886 |
| Manufacturer Phone | 5136444125 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | WOLF LUMPITIP DISSECTOR |
| Generic Name | ATRICURE LUMITIP DISECTOR |
| Product Code | GDI |
| Date Received | 2015-11-13 |
| Model Number | MID1 |
| Catalog Number | A000195 |
| Lot Number | 52949 |
| Device Expiration Date | 2017-08-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 0 |
| Device Event Key | 0 |
| Manufacturer | ATRICURE, INC. |
| Manufacturer Address | 6217 CENTRE PARK DR. WEST CHESTER OH 450693886 US 450693886 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death; 2. Hospitalization; 3. Required No Informationntervention | 2015-11-13 |