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 Insufficient Information (4580)

Event Date 01/01/2024

Event Type  malfunction  

Event Description

A medical assistant returned an unknown/ unlabeled pvak fiber that was found to be fractured.Multiple good faith effort attempts have been performed to obtain additional details regarding this device; however, no further information has been obtained.

Manufacturer Narrative

The reported defective device has to be returned to the manufacturer for a device evaluation.An investigation into the root cause for product problem is currently in progress.The results of the investigation will be sent via a follow up medwatch.Reference (b)(4).

Manufacturer Narrative

The customer's reported complaint description of the fiber fractured and detached was confirmed based on visual inspection of the returned fiber complaint sample.The likely root cause of the fiber fracture is handling damage but when and how this occurred cannot be definitively determined.The fiber tip is packaged such that the tip of the fiber is located under the coil wrap.The fraction location is in the middle of the fiber that would have been a coiled section.It cannot be determined if the fracture location was near the coil wrap.A potential contributing factor for the fiber fracture is the coil wrap and/or the process of end user removing the coil wrap from the fiber during the unpacking process.Manufacturing personnel 100% visually inspect devices during the packaging process.This type of fiber kink/detached damage would be noticed prior to shipment.A device history record review of the indicated packaging/assembly lots revealed no quality related issues or manufacturing deficiencies at the time of manufacture.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.Intended use: the venacure evlt 400 m perforator and accessory vein ablation kit is intended for use in the treatment of superficial vein reflux of the greater saphenous vein associated with varicosities.The venacure evlt 400 m perforator and accessory vein ablation kit is indicated for treatment of incompetence and reflux of superficial veins in the lower extremity, and for treatment of incompetent (i.E.Refluxing) perforator veins (ipvs).Equipment handling requirements venacure evlt 400 m perforator and accessory vein ablation kit: using sterile technique open the pack, place all contents into sterile field and inspect for damage.Do not use if any component is damaged.If damage is present, contact customer service or your local representative.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).

• 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: 18652792
• MDR Text Key: 334734361
• Report Number: 1319211-2024-00008
• Device Sequence Number: 1
• Product Code: GEX
• 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: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/23/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 5802625
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/15/2024
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/15/2024
• Initial Date FDA Received: 02/06/2024
• Supplement Dates Manufacturer Received: 03/20/2024
• Supplement Dates FDA Received: 03/23/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/16/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1