MAUDE Adverse Event Report: ANGIODYNAMICS, INC. VENACURE EVLT; NEVERTOUCH FRS 45CM PROCEDURE KIT

Catalog Number H787114030010

Device Problem Fracture (1260)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/19/2024

Event Type  malfunction  

Event Description

A territory manager reported an end user experienced an issue when using a nevertouch 65cm fiber kit.When preparing for an evlt procedure, the fiber was observed to be bent when it was removed from the packaging.A new of the same product was used to complete the procedure.The patient did not experience any adverse effects, harm, or require medical intervention because of this incident.

Manufacturer Narrative

The customer's reported complaint description of 'fiber fractured (bent)' was not confirmed due to the fiber not being returned for evaluation.Without receiving a complaint sample for evaluation, a definitive root cause cannot be determined.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 (16900393-01) 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).

Manufacturer Narrative

The customer's reported complaint of "the fiber was observed to be bent when it was removed from the packaging" is confirmed.Returned fiber sample has a fracture in the fiber shaft and tag write data shows fiber had not been used.A definitive root cause for the fiber fracture could not be determined, however, potential contributing factors include some level of stress was exerted on the fiber (shipping/transit/handling) of the fiber core material.During the manufacturing process, the disposable fiber device receives a 100% inspection and an aql inspection in which the quality of the fiber strip is inspected.Prior to packaging, all components are inspected for damage.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 (16900393-01) 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).

• Brand Name: VENACURE EVLT
• Type of Device: NEVERTOUCH FRS 45CM PROCEDURE KIT
• 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: 18800715
• MDR Text Key: 337629579
• Report Number: 1319211-2024-00030
• Device Sequence Number: 1
• Product Code: GEX
• UDI-Device Identifier: H787114030010
• UDI-Public: H787114030010
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K231945
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 05/14/2024

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
• Device Operator: Health Professional
• Device Catalogue Number: H787114030010
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/19/2024
• Initial Date FDA Received: 02/28/2024
• Supplement Dates Manufacturer Received: 04/26/2024
• Supplement Dates FDA Received: 05/14/2024
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1