MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-05-03 for HYDRO LEMAITRE VALVULOTOME 1009-00 manufactured by Lemaitre Vascular, Inc..
[145138626]
We have not received the complaint device for evaluation. Hence, at this time, 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 either in the manufacturing or packaging processes that could be related to this incident. Please note that we do conduct 100% inspection of the blades and hoops assembly during the manufacturing process. Our quality group also samples these device before final packaging to ensure proper blade adjustment. Our ifu clearly informs users to inspect the blades for damage and alignment prior to use. The surgical team confirmed that the device was properly irrigated and checked for alignment prior to use and was found to be operational. The issue occured after completing two passes successfully. It is possible that some anatomical or procedural factors may have contributed to this device failure. There was no injury to the patient as the result of this incident. Surgeon was still able to complete the procedure by using the same hydro valvulotome.
Patient Sequence No: 1, Text Type: N, H10
[145138627]
Surgeon reported that one of the blades of the hydro valvulotome did not properly close into its housing while performing valvulotomy of great saphenous vein for femoral popliteal bypass. Device was checked before use and was found to be operational. There was no harm to the patient as the result of the incident.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1220948-2019-00052 |
| MDR Report Key | 8579700 |
| Date Received | 2019-05-03 |
| Date of Report | 2019-05-03 |
| Date of Event | 2019-04-05 |
| Date Mfgr Received | 2019-04-05 |
| Device Manufacturer Date | 2018-06-28 |
| Date Added to Maude | 2019-05-03 |
| 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 | 2019-05-03 |
| Catalog Number | 1009-00 |
| Lot Number | ELVH1477VA |
| 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 | 2019-05-03 |