MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-03-01 for HYDRO EXPANDABLE LEMAITRE VALVULOTOME 1009-00 manufactured by Lemaitre Vascular, Inc..
[139325073]
We have not received the complaint device for evaluation since the device is still at the user facility. Hence, we could not conclusively determine the root cause of the defect. Our lot history records review for this lot number did not reveal any discrepancies either in the manufacturing or packaging processes that could be related to this incident. We have not received any other complaints related to a similar issue for devices from this lot number. Please note that we do conduct 100% inspection of the hoop assembly during the manufacturing process. Our manufacturing team inspect each device to ensure the blades and the hoops properly actuate and exit the retainer when the device is opened and they fully enter into the retainer and the sheath when they are closed. Our quality group also samples these devices before final packaging to ensure proper blades and hoops actuation. No defect was noted in any of the devices from this lot during inspection process. Device was not used in the patient. Another valvulotome was used for the surgery. Until product is returned from the hospital, we remain inconclusive on the exact nature of the complaint. Further information will be conveyed upon receipt of the sample.
Patient Sequence No: 1, Text Type: N, H10
[139325074]
The hoops of the valvulotome did not close properly during pre-use check.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1220948-2019-00021 |
| MDR Report Key | 8383526 |
| Date Received | 2019-03-01 |
| Date of Report | 2019-03-01 |
| Date of Event | 2019-01-31 |
| Date Mfgr Received | 2019-02-01 |
| Device Manufacturer Date | 2018-07-05 |
| Date Added to Maude | 2019-03-01 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 | 2019-03-01 |
| Catalog Number | 1009-00 |
| Lot Number | ELVH1481V |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| 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 | 2019-03-01 |