MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-05-07 for HYDRO LEMAITRE VALVULOTOME 1009-00 manufactured by Lemaitre Vascular, Inc..
[107733537]
We have received the device for evaluation. We have confirmed the reported incident. We found that one of the blade did not close properly into its retainer when the centering hoops were closed. We observed that the centering hoop that connects to this blade was damaged which led to this issue. We did not observe any damage on either side of the retainer. 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. Therefore, we believe that it was an isolated incident. At this time, we are inconclusive about the root cause of the defect. It is possible that the centering hoop was damaged during packaging or during shipping the device to the hospital. The issue was detected during pre-use check. The procedure was completed using a different valvulotome.
Patient Sequence No: 1, Text Type: N, H10
[107733538]
Before the procedure, the surgeon tested the blades functionality of the valvulotome. The surgeon was unable to close one of the blades into its housing.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1220948-2018-00027 |
| MDR Report Key | 7492544 |
| Date Received | 2018-05-07 |
| Date of Report | 2018-05-07 |
| Date of Event | 2018-04-10 |
| Date Mfgr Received | 2018-04-10 |
| Device Manufacturer Date | 2017-08-07 |
| Date Added to Maude | 2018-05-07 |
| 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 | 2018-05-07 |
| Returned To Mfg | 2018-05-01 |
| Catalog Number | 1009-00 |
| Lot Number | ELVH1317V |
| 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 | 2018-05-07 |