MAUDE Adverse Event Report: ANGIODYNAMICS VENACURE NEVERTOUCH DIRECT PROCEDURE KIT; VENACURE ENDOVENOUS LASER TREATMENT FIBER

Catalog Number	11403101
Medical Device Problem Codes	Melted (1385); Detachment of Device or Device Component (2907); Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	07/15/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Returned for evaluation was a nevertouch direct fiber, the sheath was not returned.A visual review of the fiber noted that all of the markings were present.There was burnt residue on the gold tip tube and quartz ferrule due to contact with the inside of the introducer sheath.The 16cm print mark is present and in the correct location relative to the distal tip.The printed 16cm mark on both sides of the fiber is complete.When rotating the fiber, the print marks always remain at least partially visible.The customer's reported complaint description of "the fiber was missing the 16cm marking" was not confirmed.The root cause for the sheath detaching could not be definitively determined as the sheath sample was not returned, however, likely root cause is fiber tip being pulled through the tip of the sheath during pull-back firing.Potential root cause for this pull-back damage is user error in not pulling the sheath from the vessel in conjunction with the fiber when 16cm warning mark is observed.As mentioned above, the fiber markings were correct and not a contributing factor to this event.Labeling review: the instructions for use which is supplied to the end user with this catalog number contains the following statements: "prior to and during use, avoid bending the introducer sheath and dilator as this can cause kinks and damage.Advance the nevertouch direct laser fiber through the introducer sheath to the treatment location.If treating the great saphenous vein, position the fiber tip so it is 1-2cm below the sapheno-femoral junction.Verify fiber tip position using ultrasound guidance.Procedure: carefully read all instructions and observe all warnings prior to performing the procedure.Patient complications may occur if this is not done.This procedure can be performed in the physicians' office or as an outpatient treatment under local anesthesia and should be performed by a qualified physician who has received training in these techniques.Slide the introducer sheath out of the vessel and back along the fiber.Note: if the sheath is left inside the vessel during the procedure, upon visualization of the 16cm warning mark, begin removing the sheath from the vessel in conjunction with the fiber.Note: if use with the 65 cm trè-sheath* introducer is required in place of the introducer, align the back end of the trè-sheath hub with the center of the 72cm locating mark.Note: if a trè-sheath is used, confirm the fiber tip protrudes at least 2cm past the tip of the trè-sheath prior to lasing.Verify fiber tip position using ultrasound guidance.Activate the laser by depressing the foot pedal while withdrawing the fiber (and trè-sheath introducer if applicable), at a rate that adequately delivers desired laser energy per centimeter.(810nm, 980nm lasers: 50-80 joules per cm) (1470nm lasers: 30-50 joules per cm) do not apply direct external hand pressure or force over the fiber tip during energy activation.Cease operating the laser by removing foot from the foot pedal when the fiber tip is 2 - 3 cm from the access site as indicated by markers on the shaft of the fiber (or trè-sheath introducer if applicable).The nevertouch direct fiber tip is 4 cm from the access site when the white exit marks begin and 3cm from the access site when the white exit marks terminate." 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).
Event or Problem Description
When using a nevertouch direct fiber fiber, it was noticed the 16cm warning marker was missing.The doctor continued to use the fiber, resulting in the introducer sheath being lased inside the patient's vein.Due to this issue, the procedure was terminated.The doctor checked the patient under ultrasound after the procedure but did not see any remnants of the sheath.He then ordered a ct scan for the patient, which showed the sheath tip had detached inside the patient's distal gsv.Additional information provided reported the patient is doing well, and the sheath tip was retained in the patient's calf.

• Brand Name: VENACURE NEVERTOUCH DIRECT PROCEDURE KIT
• Common Device Name: VENACURE ENDOVENOUS LASER TREATMENT FIBER
• Manufacturer (Section D): ANGIODYNAMICS; 603 queensbury avenue; queensbury NY 12804
• Manufacturer (Section G): ANGIODYNAMICS; 603 queensbury avenue; queensbury NY 12804
• Manufacturer Contact: alexandra invencio ; 26 forest street; marlborough, MA 01752 ; 5086587805
• MDR Report Key: 15173500
• Report Number: 1319211-2022-00032
• Device Sequence Number: 6213044
• Product Code: GEX
• UDI-Device Identifier: H787114031015
• UDI-Public: H787114031015
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/05/2022

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 Expiration Date: 05/31/2025
• Device Catalogue Number: 11403101
• Device Lot Number: 5737678
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/26/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/15/2022
• Initial Report FDA Received Date: 08/05/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/31/2025
• 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: 62 YR
• Patient Sex: Male