MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-10-05 for HYDRO LEMAITRE VALVULOTOME 1009-00 manufactured by Lemaitre Vascular, Inc..
[123203715]
We have not yet received the device for evaluation. Hence, we could not conclusively determine the root cause of the defect. A follow-up report will be provided after we evaluate the device. We have conducted a lot history review and did not find any issues noted in the manufacturing or packaging process that could be related to this issue. All qc tests passed their requirements. All of the 98 units from this lot released for sale have been sold. We have not received any other complaints of a similar nature for devices from this lot. At this time, we are inconclusive about the root cause of the defect. Device was not used in the patient. Another valvulotome was used for the surgery.
Patient Sequence No: 1, Text Type: N, H10
[123203716]
The cutting blades of the valvulotome did not open or close properly. The malfunction was detected during pre-use check. So, the defective device was replaced with a new valvulotome.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1220948-2018-00077 |
| MDR Report Key | 7940482 |
| Date Received | 2018-10-05 |
| Date of Report | 2018-12-07 |
| Date of Event | 2018-09-06 |
| Date Mfgr Received | 2018-09-06 |
| Device Manufacturer Date | 2017-12-08 |
| Date Added to Maude | 2018-10-05 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| 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 | 2018-10-05 |
| Returned To Mfg | 2018-10-29 |
| Catalog Number | 1009-00 |
| Lot Number | ELVH1378V |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| 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 |
|---|---|---|---|
| 0 | 0 | 2018-10-05 |