MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-04-07 for HYDRO LEMAITRE VALVULOTOME 1009-00 manufactured by Lemaitre Vascular, Inc..
[72501667]
We have received and evaluated the complaint device. We were able to confirm the reported incident. We found that one of the blades did not insert into the retainer when the centering hoops were closed. After we manually fixed the blade using a forceps, the blade inserted into the retainer and was able to close completely. No issue was noted when the centering hoop was opened and closed multiple times after fixing this defect. Our lot history records review did not reveal any discrepancies related to the complaint event either in the manufacturing or packaging processes. Please note that we do conduct 100% inspection of the blade assembly during the manufacturing process. However, it is possible that one of the blades was damaged (over tweaked) during the manufacturing process. The blade adjustment process includes manual manipulation of each blade by the operator. Operator errors, though rare, are possible due to the manual nature of the adjustments. We have implemented a corrective action for this issue. The corrective action includes use of new fixtures, evaluation of current fixtures in place and additional preventive maintenance for the fixtures. Devices from this lot was manufactured before implementation of these changes.
Patient Sequence No: 1, Text Type: N, H10
[72501668]
The blades failed to re-sheath into the retainer during pre-use check.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1220948-2017-00025 |
| MDR Report Key | 6472023 |
| Date Received | 2017-04-07 |
| Date of Report | 2017-04-07 |
| Date Mfgr Received | 2017-03-10 |
| Device Manufacturer Date | 2016-06-01 |
| Date Added to Maude | 2017-04-07 |
| 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 | 2017-04-07 |
| Returned To Mfg | 2017-03-09 |
| Catalog Number | 1009-00 |
| Lot Number | ELVH1097V |
| Operator | PHYSICIAN |
| Device Availability | R |
| 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 |
|---|---|---|---|
| 1 | 0 | 2017-04-07 |