MAUDE Adverse Event Report: ANGIODYNAMICS, INC. VENACURE EVLT; ELECTROSURGICAL, CUTTING & COAGULATION

Catalog Number	11403101
Medical Device Problem Codes	Thermal Decomposition of Device (1071); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	06/17/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer's reported complaint description of the sheath burned/melted and detached inside the patient's vein was not confirmed since no fiber or sheath complaint sample was returned.Without receiving product for evaluation we cannot confirmed the reported event.There was no report of device malfunction.The doctor reported that they forgot to remove the sheath device (along with the fiber) when the fiber reached the 16cm mark, as instructed in the device dfu.Root cause of this event is end user error.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: the instructions for use (16650430-01) 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." 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).
Additional Manufacturer Narrative
The reported device has not been returned to the manufacturer for evaluation.An investigation tino the root cause of this event 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 physician reported an issue with a nevertouch direct procedure kit.The following was reported: "while treating the anterior saphenous vein with nevertouch direct, dr.(b)(6) forgot to remove the sheath at the 16cm (b)(6) claims he did not see marking and during pullback of the short vein segment, burned the sheath and a fragment, of the sheath, was left in the vein when removing laser fiber and melted sheath.(b)(6) called me at 3:56pm with the patient in room to explain what happened.I immediately called the clinical (b)(6) and had a three-way call with the physician.We discussed how nevertouch direct retained catheter fragment.(b)(6) spoke with the physician who indicated that he lost track of the warning marks and inadvertently pulled the laser fiber into the sheath.(b)(6) had advised the physician that the fragment should be retrieved and possible cutdown since the fragment was superficial and end of the treated asv.The physician later called the tm and indicated he was able to retrieve the fragment." the patient did not experience any adverse effects or harm as a result of this event and did not require any additional anesthesia.

• Brand Name: VENACURE EVLT
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION
• 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: 19742520
• Report Number: 1319211-2024-00060
• Device Sequence Number: 3641615
• Product Code: GEI
• UDI-Device Identifier: H787114031010
• UDI-Public: H787114031010
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• 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: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/24/2024

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 Catalogue Number: 11403101
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/17/2024
• Supplement Date Received by Manufacturer: 07/17/2024
• Initial Report FDA Received Date: 07/15/2024
• Supplement Report FDA Received Date: 07/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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