MAUDE Adverse Event Report: ANGIODYNAMICS, INC. VENACURE EVLT; POWERED LASER SURGICAL INSTRUMENT

Model Number	EVLTPVAKUS
Medical Device Problem Codes	Fracture (1260); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	03/17/2025
Type of Reportable Event	Malfunction
Event or Problem Description
A medical assistant reported that the tip of the pvak -- 400 micron perforator and accessory vein ablation kit detached inside of the patient's leg., during a procedure.The following procedure information was provided: part 1 - right posterior thigh, cranial thigh extension.Tip was checked before and present after completion.Fiber was used for 11 seconds and emitted 69 joules of heat.Part 2 - right lateral calf perforator at the height of 37 centimeters.Tip was not present following insertion and use in vein.Fiber was used for 5 seconds and emitted 28.7 joules of heat.A follow up ultrasound was performed, approximately one week after the procedure, and the tip has remained in the same position; therefore, it will be left in situ.The patient has not experienced any adverse effects or harm as a result of this event.
Additional Manufacturer Narrative
The device has been returned to the manufacturer for evaluation.An investigation into the root cause for the event is currently in progress.The results of the investigation will be sent via a follow up medwatch.Reference: (b)(4).
Additional Manufacturer Narrative
The customer's reported complaint description of fiber tip fractured and detached was confirmed based on visual inspection of the returned fiber complaint sample.The od of the fiber shaft was confirmed to meet product specifications.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.A potential contributing factor for the fiber fracture is the coil wrap/mfg packaging process and/or the process of end user removing the fiber tip from inside of the coil wrap (and removing the entire coil wrap) during the unpacking process.Handling damage during device use (i.E.Insertion of fiber into the needle) is also potential contributing factor for this event.A device history record (dhr) review of the indicated packaging/assembly lots revealed no quality related issues or manufacturing deficiencies at the time of manufacture.During the manufacturing process, the disposable fiber device receives a 100% visual inspection and an aql inspection in which the quality of the fiber strip is inspected.During the packaging step, the fibers are inspected for damage.Labeling review: the directions for use which is supplied to the end user with the evlt fiber contains the following statements: 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 400m 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 400m 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 400m 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 continues to be monitored for trends.Reference (b)(4).

• Brand Name: VENACURE EVLT
• Common Device Name: POWERED LASER SURGICAL INSTRUMENT
• 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: 21774932
• Report Number: 1319211-2025-00018
• Device Sequence Number: 20898856
• Product Code: GEX
• UDI-Device Identifier: H787EVLTPVAKUS0
• UDI-Public: H787EVLTPVAKUS0
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K041957
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/29/2025

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
• Operator of Device: Health Professional
• Device Model Number: EVLTPVAKUS
• Device Lot Number: 5838913
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/31/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/17/2025
• Supplement Date Received by Manufacturer: 07/18/2025
• Initial Report FDA Received Date: 04/04/2025
• Supplement Report FDA Received Date: 07/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/22/2025
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 43 YR
• Patient Sex: Female
• Patient Weight: 82 KG