MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-01-04 for TRIVEX SYSTEM CONTROL UNIT 7201386F manufactured by Lemaitre Vascular, Inc..
[133362964]
We have not received the device for evaluation since the device is still at the hospital. Hence, we could not conclusively determine the root cause of the defect. On 12/07/2018, our sales rep. Reported to us that the connector on this control unit was pushed into its housing. So, the surgeon could not connect the handpiece cable into the connector. He then used another control unit that they have in stock to complete the phlebectomy procedure. There has been no serious injury (section 2. 13) nor would the malfunction result in a death or serious injury if it was to reoccur since the control unit could not be used for the procedure. However, we have decided to report the incident since our evaluation was based on the reported defect from our sales rep. And the user at the hospital rather than our hands-on evaluation with this defective device itself.
Patient Sequence No: 1, Text Type: N, H10
[133362965]
The connector in the control unit was pushed into the housing. The issue was detected before the procedure.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1220948-2019-00003 |
| MDR Report Key | 8219839 |
| Date Received | 2019-01-04 |
| Date of Report | 2019-01-04 |
| Date of Event | 2018-12-07 |
| Date Mfgr Received | 2018-12-07 |
| Date Added to Maude | 2019-01-04 |
| 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 |
| Generic Name | VARICOSE VEIN ALBATION SYSTEM |
| Product Code | DWQ |
| Date Received | 2019-01-04 |
| Catalog Number | 7201386F |
| Operator | HEALTH PROFESSIONAL |
| 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 02148 US 02148 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2019-01-04 |