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 2020-01-29 for TRU-INCISE VALVULOTOME TIVK2030 manufactured by Lemaitre Vascular, Inc..
[181790431]
We have not received the complaint device for evaluation. Hence, we could not conclusively determine the root cause of the failure. This valvulotome was manufactured by uresil, llc. We acquired this product line from uresil, llc. On july 2019. We could not determine if the malfunction was detected during pre-use or during usage of the device. We have reached out to the customer for clarification. However, we did not receive any response from the customer regarding this incident. At this time, we remain inconclusive about the root cause of the failure as well as the exact failure that occurred with this device.
Patient Sequence No: 1, Text Type: N, H10
[181790432]
The connector of the tru-incise valvulotome separated from its main unit. No further information was provided by the customer.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1220948-2020-00013 |
| MDR Report Key | 9644599 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-01-29 |
| Date of Report | 2020-01-29 |
| Date Mfgr Received | 2019-12-30 |
| Date Added to Maude | 2020-01-29 |
| 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 | RISK MANAGER |
| 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 | TRU-INCISE VALVULOTOME |
| Generic Name | VALVULOTOME |
| Product Code | MGZ |
| Date Received | 2020-01-29 |
| Catalog Number | TIVK2030 |
| Lot Number | 8E398 |
| 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 | 2020-01-29 |