MAUDE Adverse Event Report: ANGIODYNAMICS, INC. VENACURE EVLT; NEVERTOUCH DIRECT PROCEDURE KIT, 1 FIBER W/ SMA 905 CONNECTOR

Model Number	11403101
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	08/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported device has yet 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).
Event or Problem Description
A distributor reported an end user experienced an issue when using a nevertouch direct procedure kit.During the procedure, with about 25cm left to finish the saphene vein of the right leg, the fiber broke.The doctor wasn't forcing, she was performing the procedure as instructed.The patient had no tortuosity in this region of the leg.When the fiber broke, the tip of the fiber was left outside the introducer, making it easier to remove.They opened a 2nd fiber to finish the remaining 25cm, and performed the ablation on the left leg.
Additional Manufacturer Narrative
Corrections: d2a, e2, e3.The customer's reported complaint of the fiber was fractured/detached is confirmed.A review of the returned fiber sample showed a fracture/detachment 25cm from the distal end of the fiber.It was confirmed that the fiber had been fired, as per the event description.The od of the fiber shaft was confirmed to meet device dimensional specification.The root cause of the fiber fracture and detachment could not be definitively determined, however, handling damage during use is potential contributing factor.When the fiber core is fractured it allows laser energy to escape at that point which can melt the buffer layer and result in fiber detachment.During the manufacturing process, each fiber receives two 100% inspections to ensure that they are programed properly.A device history records search for the packaging/fiber assembly lots revealed no quality related issues or manufacturing deficiencies at the time of manufacture.Labeling review: the instructions for use (16900430-01) which is supplied to the end user with this catalog number contains the following statement "avoid damaging the fiber by striking, stressing or excessive bending.Do not coil the fiber tighter than a diameter of 16cm." the user manual (man/31/0075), which is supplied to the end user with this unit, states "before using a fiber, check it carefully for any signs of damage during storage or transit.Protective caps should be in place over sma connectors.Do not use if there is any sign of damage." 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
• Common Device Name: NEVERTOUCH DIRECT PROCEDURE KIT, 1 FIBER W/ SMA 905 CONNECTOR
• 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 ; 8007726446
• MDR Report Key: 22943689
• Report Number: 1319211-2025-00035
• Device Sequence Number: 21251884
• Product Code: GEX
• UDI-Device Identifier: H787114031010
• UDI-Public: H787114031010
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K130671
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/21/2025

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: 11403101
• Device Lot Number: 5841567
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/04/2025
• Supplement Date Received by Manufacturer: 11/19/2025
• Initial Report FDA Received Date: 09/02/2025
• Supplement Report FDA Received Date: 11/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/25/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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 Sex: Unknown