MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-03-03 for HYDRO LEMAITRE VALVULOTME manufactured by Lemaitre Vascular, Inc..
[69344912]
We cannot verify the root cause of the defect since the device was discarded by the hospital. We also could not verify the lot number of the device since we have sold them multiple lots. When sales rep. Followed-up with the hospital to find out the lot number, he was informed they do not have any records of the device since they threw everything related away. There was no injury to the patient as the result of this incident. Out of (b)(4) units sold to this hospital since 2015, we found (b)(4) devices are from the lots that we currently recalling. It is likely based on the reported incident that this complaint device is from this recall lot. We have informed the hospital to return all the devices from the recall lots on february 6, 2017. We received response from the hospital stating they have 2 units in stock and will be returning them back to us. Device discarded by user.
Patient Sequence No: 1, Text Type: N, H10
[69344913]
During femoral - at in situ bypass, blades of the valvulotome did not close inside patient's vein.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1220948-2017-00021 |
| MDR Report Key | 6377236 |
| Date Received | 2017-03-03 |
| Date of Report | 2017-03-03 |
| Date of Event | 2017-01-31 |
| Date Mfgr Received | 2017-02-03 |
| Date Added to Maude | 2017-03-03 |
| 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 VALVULOTME |
| Generic Name | VALVULOTOME |
| Product Code | MGZ |
| Date Received | 2017-03-03 |
| Lot Number | UNKNOWN |
| 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 | 2017-03-03 |