MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-03-09 for HYDRO LEMAITRE VALVULOTOME 1009-00 manufactured by Lemaitre Vascular, Inc..
[69865157]
We have not received the complaint device since it was discarded by the hospital. However, we have confirmed the failure from the picture that was provided to us before discarding the device. We found tails of the centering hoop was sticking out of the sheath preventing closure of the device. We are aware of this issue and have an ongoing recall that includes this lot number. We had notified this hospital to return all affected devices on 08/10/2016. We received response from them stating they had no devices from this lot in stock. However, they did have this device from this lot in stock and was used for this procedure. 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. However, we did initiate a corrective action to investigate and resolve complaints related to similar issues. We have implemented a design change to our device that includes a heat shrink covering of the blades. We believe this change, along with some other process improvements, will eliminate the issue that our customer experienced. There was no patient injury as the result of this incident.
Patient Sequence No: 1, Text Type: N, H10
[69865158]
Surgeon could not close the hoops of the valvulotome during the procedure.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1220948-2017-00022 |
| MDR Report Key | 6393140 |
| Date Received | 2017-03-09 |
| Date of Report | 2017-03-10 |
| Date of Event | 2017-02-06 |
| Date Mfgr Received | 2017-02-10 |
| Device Manufacturer Date | 2016-02-10 |
| Date Added to Maude | 2017-03-09 |
| 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 | 0 |
| 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 | 2017-03-09 |
| Catalog Number | 1009-00 |
| Lot Number | ELVH1083V |
| Operator | PHYSICIAN |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 0 |
| 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 | 2017-03-09 |