MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-06-12 for HYDRO LEMAITRE VALVULOTOME 1009-00 manufactured by Lemaitre Vascular, Inc..
[77516729]
We have not yet received the device for evaluation since it is still in transit. During our follow-up with the hospital, we learned that the blades of the centering hoop did not close in the closed state. 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. 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. Further, we have not received any other complaints of similar nature for devices from this lot. There was no injury to the patient as the result of this incident. We will be providing a follow-up report after we receive and evaluate the device.
Patient Sequence No: 1, Text Type: N, H10
[77516730]
During femoral-popliteal bypass, after first passage, the blades of the valvulotome did not close.
Patient Sequence No: 1, Text Type: D, B5
[96649431]
This is a follow-up report to the report 1220948-2017-00040 that was initially submitted on (b)(6) 2017. 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 intermittently when the centering hoops were opened and closed multiple times. We also confirmed that it was the same blade that did not insert into the retainer. 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 possible that the device was damaged during the manufacturing process or after inspection and prior to packaging. As a result, we have implemented corrective action to minimize the possibility of this recurring.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1220948-2017-00040 |
| MDR Report Key | 6635218 |
| Date Received | 2017-06-12 |
| Date of Report | 2017-07-11 |
| Date of Event | 2017-05-02 |
| Date Mfgr Received | 2017-05-12 |
| Device Manufacturer Date | 2016-10-26 |
| Date Added to Maude | 2017-06-12 |
| 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 | 2017-06-12 |
| Returned To Mfg | 2017-06-23 |
| Catalog Number | 1009-00 |
| Lot Number | ELVH1155V |
| Operator | PHYSICIAN |
| Device Availability | R |
| Device Age | DA |
| 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 | 2017-06-12 |