MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-05-26 for HYDRO LEMAITRE VALVULOTOME 1009-00 manufactured by Lemaitre Vascular, Inc..
[76239872]
We have received the device for evaluation and we have confirmed the reported incident. We found that the centering hoops did not close all the way inside the sheath when the green handle was pulled. The device was able to close when held straight but could not close completely when we tried to close the hoops in u-configuration. We could not conclusively determine the root cause of the defect. The investigation is ongoing. It is possible the friction between the inside wall of the sheath and the wire caused by dried blood inside the catheter has contributed to this issue. Our review of the lot history records for this lot did not find any discrepancies either in the manufacturing or packaging process that could be related to this incident. Further, we have not received any other complaints of similar nature for devices from this lot. Since the catheter was removed in the open position, the blade cut the distal end of the patient's saphenous vein. The vein was still used successfully for bypass and was able to be anastomosed to the artery.
Patient Sequence No: 1, Text Type: N, H10
[76239873]
During second passage of in-situ bypass, physician could not close the blades into the retainer while pulling the catheter at the distal end of the vein. Also, they could not completely open the catheter. So, the physician pulled the catheter reluctantly and cut the distal end of the vein since the centering hoops were removed in the open position.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1220948-2017-00035 |
| MDR Report Key | 6595203 |
| Date Received | 2017-05-26 |
| Date of Report | 2017-05-25 |
| Date of Event | 2017-04-20 |
| Date Mfgr Received | 2017-04-26 |
| Device Manufacturer Date | 2016-08-25 |
| Date Added to Maude | 2017-05-26 |
| 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 | MR. PRAGYA THIKEY |
| Manufacturer Street | 63 SECOND AVE |
| Manufacturer City | BURLINGTON MA 01803 |
| Manufacturer Country | US |
| Manufacturer Postal | 01803 |
| Manufacturer Phone | 7812212266 |
| Manufacturer G1 | LEMAITRE VASCULAR, INC. |
| Manufacturer Street | 63 SECOND AVE |
| Manufacturer City | BURLINGTON MA 01803 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 01803 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | HYDRO LEMAITRE VALVULOTOME |
| Generic Name | VALVULOTOME |
| Product Code | MGZ |
| Date Received | 2017-05-26 |
| Returned To Mfg | 2017-05-11 |
| Catalog Number | 1009-00 |
| Lot Number | ELVH1125V |
| Operator | PHYSICIAN |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | LEMAITRE VASCULAR, INC. |
| Manufacturer Address | 63 SECOND AVE BURLINGTON MA 01803 US 01803 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other; 2. Required No Informationntervention | 2017-05-26 |