MAUDE Adverse Event Report: ANGIODYNAMICS, INC. VENACURE EVLT; VENACURE 400 MICRON PERFORATOR AND ACCESSORY VEIN ABLATION KIT

Catalog Number H787EVLTPVAKUS5

Device Problem Fracture (1260)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/23/2024

Event Type  malfunction  

Manufacturer Narrative

The device evaluation is ongoing.Should additional relevant information become available, a supplemental report will be submitted.

Event Description

An end user reported an issue with two pvak: 400 micron perforator and accessory vein ablation kits.While unpacking, the fibers were found to be damaged at the tip.The following procedure was completed with another same device and the patient did not experience any adverse effects, harm, or require medical intervention as a result of this incident.Device 1 of 2.

• Brand Name: VENACURE EVLT
• Type of Device: VENACURE 400 MICRON PERFORATOR AND ACCESSORY VEIN ABLATION KIT
• Manufacturer (Section D): ANGIODYNAMICS, INC.; 603 queensbury avenue; queensbury NY 12804
• Manufacturer (Section G): ANGIODYNAMICS, INC.; 603 queensbury avenue; queensbury NY 12804
• Manufacturer Contact: alexandra invencio ; 26 forest street; marlborough, MA 01752 ; 5086587990
• MDR Report Key: 18891476
• MDR Text Key: 337850361
• Report Number: 1319211-2024-00037
• Device Sequence Number: 1
• Product Code: GEX
• UDI-Device Identifier: H787EVLTPVAKUS5
• UDI-Public: H787EVLTPVAKUS5
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K041957
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/12/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/12/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: H787EVLTPVAKUS5
• Device Lot Number: 5806941
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/23/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/11/2023
• Type of Device Usage: Initial
• Patient Sequence Number: 1