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 customer's reported complaint description of "while unpacking the kit, the fiber was found to be fractured at the tip" was not confirmed due to no sample being returned for evaluation.Without receiving the complaint sample for evaluation, a definitive root cause could not be determined.A review of the device history records was performed for the indicated lots for any deviations related to the reported failure mode of the complaint.The review confirms that the lots met all material, assembly and performance specifications; i.E.No ncr associated with reported failure mode.Labeling review: the directions for use (14601411-01) which is supplied to the end user with the reported catalog number contains the following statement: warning: contents supplied sterile using an ethylene oxide (eo) process.Do not use if sterile barrier is damaged.If damage is found, call your sales representative.Inspect prior to use to verify that no damage has occurred during shipping.A review of the angiodynamics complaint system noted no adverse trends for this complaint type and product family.This type of complaint will continue to be monitored for trends.Reference (b)(4), 1319211-2024-00037, device 1 of 2.Reference (b)(4), device 2 of 2.

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 2 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: 18891508
• MDR Text Key: 337791362
• Report Number: 1319211-2024-00038
• 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