MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-02-08 for HYDRO LEMAITRE VALVULOTOME 1009-00J manufactured by Lemaitre Vascular, Inc..
[67227793]
We have received and confirmed the reported failure. We found tails of the centering hoop 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 early (b)(6) 2016. We received response from them dated september 13 stating they do not have any device from this lot in stock. After this incident occured, we were notified that they had three more devices from this lot in stock and will be returning back to us. There was no injury to the patient. The physician trimmed the hood of the vein and completed the anastomosis.
Patient Sequence No: 1, Text Type: N, H10
[67227794]
During the procedure, cutting head did not resheath since it was caught on the sheath of the catheter. Device kinked upon resheathing.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1220948-2017-00006 |
| MDR Report Key | 6310490 |
| Date Received | 2017-02-08 |
| Date of Report | 2017-02-07 |
| Date of Event | 2017-01-09 |
| Date Mfgr Received | 2017-01-10 |
| Device Manufacturer Date | 2016-05-18 |
| Date Added to Maude | 2017-02-08 |
| 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 | 2017-02-08 |
| Returned To Mfg | 2017-02-01 |
| Catalog Number | 1009-00J |
| Lot Number | ELVH1078V |
| Operator | PHYSICIAN |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| 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 | 2017-02-08 |