MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-03-14 for TRIVEX SYSTEM RESECTOR HANDPIECE 7201387F manufactured by Lemaitre Vascular, Inc..
[138970074]
We have not received the device for evaluation. Hence, we could not conclusively determine the root cause of the defect. The contact person at the hospital stated that the device was picked up by (b)(6). However, the tracking information for this device shows that this unit has not been received by (b)(6). Prior to the procedure, after plugging the handpiece connector into the control unit, the indicator light on the control unit began flashing orange light indicating an issue with the handpiece and the handpiece was found to be non-operational. There has been no serious injury nor the malfunction would result in a death or serious injury if it was to reoccur since the handpiece 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. The issue was detected during pre-use check. Handpiece was not used in the patient. The procedure was completed using a different handpiece.
Patient Sequence No: 1, Text Type: N, H10
[138970075]
Handpiece did not operate during pre-use check.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1220948-2019-00026 |
| MDR Report Key | 8422451 |
| Date Received | 2019-03-14 |
| Date of Report | 2019-03-14 |
| Date of Event | 2019-02-15 |
| Date Mfgr Received | 2019-02-15 |
| Date Added to Maude | 2019-03-14 |
| 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 RESECTOR HANDPIECE |
| Generic Name | VARICOSE VEIN ALBATION SYSTEM |
| Product Code | DWQ |
| Date Received | 2019-03-14 |
| Catalog Number | 7201387F |
| Device Expiration Date | 2017-07-17 |
| 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 | 2019-03-14 |