MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-12-19 for TRIVEX SYSTEM CONTROL UNIT WITH BUILT IN PUMP 7210386F manufactured by Lemaitre Vascular, Inc..
[131801755]
We have received the device for evaluation and we have confirmed the reported incident from the picture of the defect provided to us by the hospital. The control unit connector had come loose, pressed into the control unit and could not make a connection with the pins of the handpiece cable. The operator could have pushed the handpiece cable too hard to connect into the connector of the control unit. As a result, some nuts inside the port could have loosened up and resulted in this issue. There was no injury to the patient as the result of this incident. However, they had to postponed the procedure to a later date since they did not have any other control unit in stock at that time to complete the procedure.
Patient Sequence No: 1, Text Type: N, H10
[131801756]
During transilluminated powered phlebectomy surgery (tipp), the handpiece failed to operate since it could not make a proper connection with the control unit. As a result, surgeon had to postpone the procedure to a later time since they did not have any other control unit in stock at that time to complete the procedure.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1220948-2018-00110 |
| MDR Report Key | 8181195 |
| Date Received | 2018-12-19 |
| Date of Report | 2018-12-19 |
| Date of Event | 2018-11-19 |
| Date Mfgr Received | 2018-11-19 |
| Date Added to Maude | 2018-12-19 |
| 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 | 2018-12-19 |
| Returned To Mfg | 2018-12-12 |
| Catalog Number | 7210386F |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | LEMAITRE VASCULAR, INC. |
| Manufacturer Address | 63 SECOND AVE BURLINGTON MA 02148 US 02148 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-12-19 |