MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-04-17 for HYDRO LEMAITRE VALVULOTOME 1009-00 manufactured by Lemaitre Vascular, Inc..
[145772129]
We have received the device for evaluation and it is confirmed that one of the centering hoops/blades is caught on the retainer slot. We did pull on the green handle to close the centering hoops/blades and observed that another hoop/blade was protruding out of the retainer slot and didn't seat properly. The device hoops/blades were opened and closed again and all hoops/blades acted properly without further incident. The device was opened and closed several additional times without further issues. We reviewed the lot history records for this lot number and did not find any discrepancies that would contribute to this incident. Our complaint history analysis showed that no other similar complaints were found on this lot number. Please note that we perform a 100% visual inspection of the hoop/blade assembly during the manufacturing process and our quality group does a sampling of the lot prior to packaging. Our instructions for use inform users to inspect the hoop/blades for damage and alignment prior to use. In this case, the user properly followed the instructions and properly identified the issue. At this time, we are unable to determine the root cause of the defect. It is possible the hoop/blade was misaligned during packaging or during shipment to the facility. It is also possible the device was mis-handled at the facility prior to the pre-use check. Prior to this lot being built we implemented a series of improvements to our manufacturing process to resolve similar issues. The corrective actions taken have reduced the rate of these types of incidents. Device was not used in the patient. Procedure was completed using another valvulotome that they have in stock.
Patient Sequence No: 1, Text Type: N, H10
[145772130]
During pre-use check, the surgeon noticed one of the four centering hoops/blades was caught on the housing (or retainer) slot. The device was not used during the procedure.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1220948-2019-00043 |
| MDR Report Key | 8524706 |
| Date Received | 2019-04-17 |
| Date of Report | 2019-04-17 |
| Date of Event | 2019-03-13 |
| Date Mfgr Received | 2019-03-18 |
| Device Manufacturer Date | 2018-08-02 |
| Date Added to Maude | 2019-04-17 |
| 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 | 2019-04-17 |
| Returned To Mfg | 2019-04-01 |
| Catalog Number | 1009-00 |
| Lot Number | ELVH1493V |
| 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 | 2019-04-17 |