MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-02-15 for HYDRO LEMAITRE VALVULOTOME 1009-00 manufactured by Lemaitre Vascular, Inc..
[67938206]
We have received and evaluated the complaint device. We were able to confirm the reported incident. One tail of the centering hoop was protruding out of the sheath preventing closure of the device. Our review of the lot history records for this lot did not find any discrepancies that in either the manufacturing or packaging process that could be related to this incident. However, we did initiate a corrective action on 7/17/2016 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. We are aware of this issue and have an ongoing recall that includes this lot number. We have informed this hospital regarding this issue on february 10, 2017. Sales office at (b)(4) have confirmed that this hospital had no more inventory of elvh1113v.
Patient Sequence No: 1, Text Type: N, H10
[67938207]
During valvulotomy, doctor felt strong resistance as he was closing the blades of the valvulotome. In order to take the catheter out of the vein, he opened the proximal site of the anastomosis and exposed about 15 cm from the catheter tip. He then cut the catheter and took out the separated catheter from the vessel.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1220948-2017-00009 |
| MDR Report Key | 6333463 |
| Date Received | 2017-02-15 |
| Date of Report | 2017-02-14 |
| Date of Event | 2017-01-18 |
| Date Mfgr Received | 2017-01-23 |
| Device Manufacturer Date | 2016-08-11 |
| Date Added to Maude | 2017-02-15 |
| 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 | 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 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 | 2017-02-15 |
| Returned To Mfg | 2017-01-26 |
| Catalog Number | 1009-00 |
| Lot Number | ELVH1113V |
| 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 | 1. Required No Informationntervention | 2017-02-15 |