MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-02-07 for TRIVEX SYSTEM CONTROL UNIT WITH BUILT IN PUMP 7210386F manufactured by Lemaitre Vascular, Inc..
[136919841]
We have received the complaint device for evaluation. However, we were unable to replicate the reported defect during our evaluation. The control unit was found to be functioning properly at all settings and speeds. The control unit was tested multiple times but we did not observe any failure with the control unit. During the procedure at the hospital, the indicator light on the control unit properly flashed orange indicating an issue with the handpiece. The surgeon then exchanged the handpiece and then increased the rpm on this control unit which resolved this issue. We have subsequently evaluated three handpieces that were returned from this hospital that may have been used in this case. Our evaluation found two of the three handpieces were operating intermittently. It is possible that a faulty handpiece led to this incident rather than the control unit which was evaluated to be fully functional. There was no injury to the patient as the result of this incident.
Patient Sequence No: 1, Text Type: N, H10
[136919842]
During transilluminated powered phlebectomy (tipp), the control unit stopped working periodically flashing orange light on the control unit.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1220948-2019-00010 |
| MDR Report Key | 8318309 |
| Date Received | 2019-02-07 |
| Date of Report | 2019-02-07 |
| Date of Event | 2018-10-17 |
| Date Mfgr Received | 2018-10-17 |
| Date Added to Maude | 2019-02-07 |
| 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 | TRIVEX SYSTEM CONTROL UNIT WITH BUILT IN PUMP |
| Generic Name | VARICOSE VEIN ALBATION SYSTEM |
| Product Code | DWQ |
| Date Received | 2019-02-07 |
| Returned To Mfg | 2018-12-03 |
| Catalog Number | 7210386F |
| 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 | 2019-02-07 |