MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-03-24 for HYDRO LEMAITRE VALVULOTOME 1009-00 manufactured by Lemaitre Vascular, Inc..
[71063586]
We have received and evaluated the complaint device. We were able to confirm the reported incident. Initially, when we observed the device, we found two of the blades were protruding out of the retainer when the centering hoops were closed. When we opened the hoop, we found only one of the blade was projecting out of the retainer. We also found that it was the same blade that did not close into the retainer when the centering hoops were opened and closed multiple time. After we manually fixed the blade using forceps, the blade inserted into the retainer and was able to close completely. No issue was noted when the centering hoops were opened and closed multiple times after fixing this defect. We have initiated a corrective action (capa) to investigate this issue. 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. Our quality control also samples these devices before final packaging to ensure proper blade adjustment. It is highly unlikely that the product was packaged with this defect. When we initially contacted the hospital, the physician could not remember if he had checked this device before use for this attribute. A follow-up with the hospital revealed that this issue occurred after the second or third usage of the device which implies that the device functioned properly when pre-use checked. While it is still possible that our inspection did not detect this issue, it is more likely 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.
Patient Sequence No: 1, Text Type: N, H10
[71063587]
Blades of the valvulotome did not close during the procedure.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1220948-2017-00024 |
| MDR Report Key | 6432154 |
| Date Received | 2017-03-24 |
| Date of Report | 2017-03-23 |
| Date of Event | 2017-02-16 |
| Date Mfgr Received | 2017-02-22 |
| Device Manufacturer Date | 2016-09-07 |
| Date Added to Maude | 2017-03-24 |
| 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 | 2017-03-24 |
| Returned To Mfg | 2017-03-17 |
| Catalog Number | 1009-00 |
| Lot Number | ELVH1130V |
| 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 | 2017-03-24 |