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

Model Number	11403001
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/25/2025
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
An end user reported an issue with a nevertouch 45cm kit w/gripper and rfid t.The fiber was being used in an ablation case, when it fractured and burned a hole through the sterile drapes on the field.All safety measures had been followed prior to this.No part of the fiber was inside of the patient at the time.
Event or Problem Description
Event description correction: an fda medsun program report was received via email which reported that an end-user facility experienced an issue with a "nevertouch 45cm kit w/gripper and rfid t' device.During a patient's right accessory saphenous vein endovenous laser ablation (evla) procedure, the fiber fractured inside of the patient.The device fragment was removed via a cut-down/snare procedure.Additionally, it was reported that the fractured fiber burned a hole through the sterile drapes on the sterile field after it had been removed from the patient.The end-user reported that all safety measures were being following per protocol prior to the reported issue.
Additional Manufacturer Narrative
Correction: b5 describe event or problem - updated to report the fiber fractured while inside the patient.Reference (b)(4).
Additional Manufacturer Narrative
The customer's reported complaint of the fiber was fractured/detached is confirmed.A review of the returned fiber sample showed a fracture/detachment 124.2cm 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.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.During the manufacturing process, each fiber receives two 100% inspections to ensure that they are programed properly.Labeling review: the directions for use (dfu), which is supplied to the end user with this catalog number, states: "prior to and during use, avoid damaging the fiber by striking, stressing, or excessive bending.Do not coil the fiber tighter than a diameter of 20cm.Clinical safety and effectiveness data is not available for other fiber tip designs and diameters.Prior to and during use, avoid bending the introducer sheath and dilator as this can cause kinks and damage".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: POWEERED 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 ; 8007726446
• MDR Report Key: 22942935
• Report Number: 1319211-2025-00036
• Device Sequence Number: 9878376
• Product Code: GEX
• UDI-Device Identifier: H787114030010
• UDI-Public: H787114030010
• Combination Product (Y/N): N
• Initial Reporter State: ME
• Initial Reporter Country: US
• PMA/510(K) Number: K171921
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/23/2026

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: 11403001
• Device Lot Number: 5841563
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/13/2025
• Supplement Date Received by Manufacturer: Not provided; 02/18/2026
• Initial Report FDA Received Date: 09/02/2025
• Supplement Report FDA Received Date: 09/17/2025; 02/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/21/2025
• 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 Age: 61 YR
• Patient Sex: Female
• Patient Weight: 93 KG