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

Model Number	11403001
Medical Device Problem Codes	Fracture (1260); Flare or Flash (2942)
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 an evlt fiber and a venacure 1470 laser unit.It was reported the laser unit burned the fiber off at the gripper section (frs gripper had caught fire).The fiber was inside the patient at the time, and was subsequently removed.A new fiber was used to complete the procedure.They requested to have the unit returned for evaluation and pm/calibration.
Additional Manufacturer Narrative
The customer's reported complaint description of tre-sheath tubing was burnt/melted and detached was confirmed.The returned tre-sheath complaint sample was noted to be detached at the 0cm mark with ends of tubing burnt/melted.There was no damage/fracture observed during evaluation of the returned fiber shaft.The distal end of the gold tip has remnants of the melted tre-sheath tubing, indicating that this was the source of the burnt tre-sheath tubing.This would mean end user would have activated the laser with the gold tip inside the tre-sheath tubing.The fiber should only be fired when the gold tip is positioned just distal of the tre-sheath tubing.Root cause of this event was confirmed to be handling damage to the tre-sheath tubing during use, i.E.End user firing the laser generator when the fiber tip was inside of the tre-sheath tubing.Hardware unit review: the serial number of the solero generator hardware unit used during this event was reported as (b)(6).Service case (b)(4) was opened to investigate the performance of the hardware unit in regards to this complaint event.Evaluation of the returned unit showed no damage and passed functional testing; the reported complaint event could not be duplicated.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: directions for use (dfu, 16900393-01) is provided with the fiber kit.Review of the returned complaint sample showed indication that the fiber was not used in accordance with its labeling since the fiber stop assembly was not removed and tre-sheath hub could not have been connected to the sheath-lok fitting.Dfu contains the following statements.Procedure: insert the nevertouch laser fiber into the sheath until the fiber stop assembly comes in contact with the end of the sheath hub.[see picture in dfu] remove fiber stop assembly.Pull the sheath back and lock it to the sheath-lok fitting.Confirm location of the fiber using ultrasound guidance.The nevertouch fiber end should be 2 cm below the sapheno-femoral junction when treating the gsv.Move the sliding sheath gauge until flush with the insertion site, to mark the final position of the sheath.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.(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 ; 8007726446
• MDR Report Key: 22701062
• Report Number: 1319211-2025-00033
• Device Sequence Number: 9037431
• Product Code: GEX
• UDI-Device Identifier: H787114030010
• UDI-Public: H787114030010
• Combination Product (Y/N): N
• Initial Reporter State: AL
• 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: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/29/2026

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: 5838620
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/25/2025
• Supplement Date Received by Manufacturer: 01/26/2026
• Initial Report FDA Received Date: 08/04/2025
• Supplement Report FDA Received Date: 01/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/22/2025
• 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