MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-01-16 for HYDRO LEMAITRE VALVULOTOME 1009-00 manufactured by Lemaitre Vascular, Inc..
[134733770]
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 either in the manufacturing or packaging processes that could be related to this incident. We have not received any other complaints related to a similar issue for devices from this lot number. Please note that we do conduct 100% inspection of the blade assembly during the manufacturing process. Our quality group also samples these device before final packaging to ensure proper blade adjustment. It is possible that the blade was damaged during packaging or during shipping the device to the hospital. Our ifu clearly informs users to inspect the blades for damage and alignment prior to use. In this case, the user properly followed the risk mitigation measures (ifu) and properly identified the issue. Device was not used in the patient. Another valvulotome was used for the surgery.
Patient Sequence No: 1, Text Type: N, H10
[134733771]
One of the four cutting blades of the valvulotome did not close properly into its housing. The malfunction was detected by the surgeon during pre-use check. So, the defective device was replaced with a new valvulotome.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1220948-2019-00005 |
| MDR Report Key | 8254720 |
| Date Received | 2019-01-16 |
| Date of Report | 2019-01-16 |
| Date of Event | 2018-12-17 |
| Date Mfgr Received | 2018-12-17 |
| Device Manufacturer Date | 2018-06-28 |
| Date Added to Maude | 2019-01-16 |
| 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 | 2019-01-16 |
| 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 | 2019-01-16 |