MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-04-28 for HYDRO LEMAITRE VALVULOTOME 1009-00 manufactured by Lemaitre Vascular, Inc..
[74178716]
We have not received the device for evaluation since it was discarded by the hospital. However, we have received another unopened device from the same lot that was returned from this hospital. When we evaluated this device, we did not find any issue. All of the blades were able to insert into the retainer when the device was opened and closed multiple times. And passed all of our specifications. The complaint device was tested before the procedure by the surgeon and was found to be working as expected. The different unopened returned device that we evaluated from the same lot was found to be working as expected and meets our specification. It is possible that the root cause of this defect is due to anatomy of the patient's vein or the operator's manipulation of the device during use. (b)(4) units were manufactured under this lot number. We have sold all of the (b)(4) units. 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. Further, we have not received any other complaints of similar nature for devices from this lot. Device has been discarded by hospital.
Patient Sequence No: 1, Text Type: N, H10
[74178717]
During in-situ bypass of the saphenous vein, the vein was cut during the first passage of the valvulotome. It was not possible to close the device inside the vein at the time of removal, as a result, it cut the distal 10 cm of the vein. However, device closed as expected outside of the vein. Because of the injury to the vein, the surgeon had to perform a composite bypass since the remaining vein was not long enough.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1220948-2017-00031 |
| MDR Report Key | 6531095 |
| Date Received | 2017-04-28 |
| Date of Report | 2017-04-28 |
| Date Mfgr Received | 2017-03-30 |
| Device Manufacturer Date | 2016-08-25 |
| Date Added to Maude | 2017-04-28 |
| 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 | 2017-04-28 |
| Catalog Number | 1009-00 |
| Lot Number | ELVH1127V |
| Operator | PHYSICIAN |
| 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 | 1. Other; 2. Required No Informationntervention | 2017-04-28 |