MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-04-27 for HYDRO LEMAITRE VALVULOTOME 1009-00 manufactured by Lemaitre Vascular, Inc..
[106970634]
We have received and evaluated one of the two complaint devices ( lot# elvh1367v) since the other unit was discarded by the hospital. Please refer to manufacturer's report number 1220948-2018-00025 for another report. 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. Once this blade was manually fixed, all of the blades entered and exited the housing/retainer properly upon closure of the hoops. We opened and closed the blades multiple times. All of the blades closed properly. Our lot history records review for lot number elvh1367v 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 group also samples these devices before final packaging to ensure proper blade adjustment. However, it is possible that one of the blades was not well aligned during the manufacturing process. The blade alignment process includes manual adjustment of each blade by the operator. Operator errors, though rare, are possible due to the manual nature of the adjustments. While we are inconclusive about the exact root cause of this defect, we have previously implemented a corrective and preventive action (capa) to resolve this type of issue. In the capa we made a series of improvements and replacements to our manufacturing fixtures to resolve this issue. The device in this report represents the first complaint of this type since implementation of the corrective actions. The complaint rate since implementation is currently (b)(4) units ((b)(4)%). We have not received any other complaints related to this issue on devices manufactured after completion of the corrective actions. The current reported rate of occurrence for this defect is (b)(4)%, which is within our expected rate of occurrence and is in line with our risk documentation. We believe that the corrective actions we have implemented have adequately reduced the rate of occurrence. Our ifu clearly informs users to inspect the blades for damage and alignment prior to use. In this case, the user properly followed the risk mitigation measures (ifu) and properly identified the issue.
Patient Sequence No: 1, Text Type: N, H10
[106970635]
Before the procedure, the surgeon tested the blades functionality of the valvulotome. The blades opened properly but the surgeon was unable to close one of the blades into its housing. So, he opened the second device but found the same issue with this device as well. The lot number of the first device could not be determined. The lot number of the second device is elvh1367v. Based on the description, this is report 1 of 2.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1220948-2018-00024 |
| MDR Report Key | 7469555 |
| Date Received | 2018-04-27 |
| Date of Report | 2018-04-27 |
| Date of Event | 2018-03-26 |
| Date Mfgr Received | 2018-03-28 |
| Device Manufacturer Date | 2017-11-22 |
| Date Added to Maude | 2018-04-27 |
| 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 | 2018-04-27 |
| Returned To Mfg | 2018-04-23 |
| Catalog Number | 1009-00 |
| Lot Number | ELVH1367V |
| 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 | 2018-04-27 |