MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2018-10-17 for 2.0 MM OVER-THE-WIRE LEMAITRE VALVULOTOME 1005-00 manufactured by Lemaitre Vascular, Inc..
[124077473]
We have not received the complaint device for evaluation since the device has been discarded by the hospital. Hence, we could not conclusively determine the root cause of the defect. Our lot history records review for this lot number did not reveal any discrepancies related to the complaint event either in the manufacturing or the packaging processes. Further, we have not received any other complaints of a similar nature for devices from this lot. Therefore, we believe that it was an isolated incident. Please note that we do conduct 100% inspection of the blade assembly during the manufacturing process. Our quality control also samples these devices before final packaging to ensure proper blade adjustment. It is possible the blade or the centering hoop was damaged during the procedure influenced by patient's anatomy/condition or the operator's manipulation of the device during use since the device was found to be operational during preuse check. Our ifu properly warns users not to rotate the device in a vessel and not to advance the centering hoops in an open configuration as it may cause injury to the vein. Surgeon sutured the cut section of the vein using 6. 0 prolene. Sales rep. On (b)(6) 2018 stated that the patient was doing fine in regards to the bypass.
Patient Sequence No: 1, Text Type: N, H10
[124077474]
During femoral posterior tibial in-situ bypass, the cutting blades of the valvulotome cut the great saphenous vein about 4-5 cm above the distal end. 6. 0 prolene was used to suture the cut section of the vein.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1220948-2018-00084 |
| MDR Report Key | 7975612 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2018-10-17 |
| Date of Report | 2018-10-17 |
| Date of Event | 2018-09-17 |
| Date Mfgr Received | 2018-08-17 |
| Device Manufacturer Date | 2014-09-28 |
| Date Added to Maude | 2018-10-17 |
| 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 | 3 |
| Brand Name | 2.0 MM OVER-THE-WIRE LEMAITRE VALVULOTOME |
| Generic Name | VALVULOTOME |
| Product Code | MGZ |
| Date Received | 2018-10-17 |
| Catalog Number | 1005-00 |
| Lot Number | ELV61045V |
| Device Expiration Date | 2019-08-28 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| 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. Required No Informationntervention | 2018-10-17 |