MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2018-05-11 for HYDRO LEMAITRE VALVULOTOME 1009-00 manufactured by Lemaitre Vascular, Inc..
[108050926]
We have not received the complaint device for evaluation since the device has been discarded by the hospital. Hence, we could not conclusively determine the root cause of the defect. Our lot history record review for this lot number did not reveal any discrepancies related to the complaint event either in the manufacturing or the 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 likely the blade or the centering hoop was damaged during the procedure influenced by patient's anatomy/condition since the device was found to be operational during preuse check. Surgeon was able to maneuver the device back and forth and remove it from the patient's vessel without any injury.
Patient Sequence No: 1, Text Type: N, H10
[108050927]
Surgeon was unable to completely reseath the blades of the valvulotome back into its housing during the procedure. As a result, the vessel got caught on a side branch.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1220948-2018-00029 |
| MDR Report Key | 7507527 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2018-05-11 |
| Date of Report | 2018-05-11 |
| Date Mfgr Received | 2018-04-12 |
| Device Manufacturer Date | 2016-08-25 |
| Date Added to Maude | 2018-05-11 |
| 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 | 3 |
| Brand Name | HYDRO LEMAITRE VALVULOTOME |
| Generic Name | VALVULOTOME |
| Product Code | MGZ |
| Date Received | 2018-05-11 |
| Catalog Number | 1009-00 |
| Lot Number | ELVH1122V |
| Operator | PHYSICIAN |
| 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 | 1. Required No Informationntervention | 2018-05-11 |