MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-02-14 for HYDRO EXPANDABLE LEMAITRE VALVULOTOME 1009-00 manufactured by Lemaitre Vascular, Inc..
[136894335]
We have received the device for evaluation and we have confirmed the reported incident. We observed that one of the blades was protruding out of the retainer in its closed configuration. The centering hoop of this same blade was also found bent. Our lot history records review for lot number elvh1147v 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. It is possible that the blade was damaged during packaging or during shipping the device to the hospital. While we are inconclusive about the exact root cause of the defect in this device, we have implemented a corrective and preventive action (capa) to resolve this type of issue. In the capa, we have made a series of improvements and replacements to our manufacturing fixtures to resolve this issue. The corrective actions that we have implemented have reduced the rate of failure with this device for this issue. 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. Device was not used in the patient. Another valvulotome was used for the surgery.
Patient Sequence No: 1, Text Type: N, H10
[136894336]
Surgeon was unable to close one of the blades of the valvulotome into its housing during pre-use check.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1220948-2019-00012 |
| MDR Report Key | 8341065 |
| Date Received | 2019-02-14 |
| Date of Report | 2019-02-14 |
| Date of Event | 2019-01-15 |
| Date Mfgr Received | 2019-01-15 |
| Device Manufacturer Date | 2016-09-30 |
| Date Added to Maude | 2019-02-14 |
| 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 EXPANDABLE LEMAITRE VALVULOTOME |
| Generic Name | VALVULOTOME |
| Product Code | MGZ |
| Date Received | 2019-02-14 |
| Returned To Mfg | 2019-01-25 |
| Catalog Number | 1009-00 |
| Lot Number | ELVH1147V |
| Operator | HEALTH PROFESSIONAL |
| 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 | 2019-02-14 |