MAUDE Adverse Event Report: ANGIODYNAMICS 400 MICRON FIBER PROCEDURE KIT; VENACURE ENDOVENOUS LASER TREATMENT FIBER

Catalog Number EVLTPVAK

Device Problem Fracture (1260)

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

Event Date 09/23/2022

Event Type  malfunction  

Manufacturer Narrative

It was reported that the device is not available to be returned to the manufacturer for evaluation.The results of the investigation will be sent via a follow up medwatch.Reference: (b)(4).

Event Description

A physician reported an issue with this pvak -- 400 micron perforator and accessory vein ablation kit.During unpacking, the fiber was found to be bent and appeared as if the coating was missing.Despite these issues, the physician opted to use the fiber for a procedure and the heat from the laser fiber, bent the needle.The physician reported this issue as there was concern for a potential patient burn.The physician was advised to not use damaged fibers, in the future.Ultimately, the patient did not experience any adverse effects, harm, or require medical intervention as a result of this incident.

Manufacturer Narrative

As the reported device was not returned, angiodynamics is unable to perform a device evaluation.Although the samples were not returned, the customer provided a photo which shows the needle was bent.  the photo of the fiber doesn't show the reported defect of fiber fractured.The fiber assembly was not returned and therefore an investigation into the likely root cause of the damage to the fiber could not be determined.  the customer's reported complaint description of fiber fractured and fiber coating missing could not be confirmed based on the photo provided as the bend of the fiber and missing coating was not shown.  the needle bent after use was confirmed due to the provided photo.Although the complaint for the needle being bent was confirmed based on the photo provided, a definitive root cause for the customer experience with this fiber and accessory devices could not be determined.  it was reported that the customer noted the fiber fractured and chose to use device anyway.The root cause for the needle becoming bent was due to the end user using the known bent fiber which cause the needle to bend due to the laser heat escaping the broken fiber that was inside the needle while the fiber was fired.The absorption of laser energy can result in rapid heating as is evident from the picture of the needle cannula.The laser energy is intended to exit the distal tip of the fiber assembly which is directed into an area of a vein where heating of the blood is intended to occur to achieve a desired result.Laser energy directed to an unintended area can have an adverse result.Even though numerous steps are taken to ensure the integrity of each fiber assembly, it is incumbent on the end user to note any obvious abnormality and not use a device that may be compromised.Per the directions for use instructions supplied with pvak fiber assemblies, it is stated "do not use if any component is damaged".    at the vendor facility, during the manufacturing process, fibers are repeatedly bent and coiled and there is a final visual inspection performed with a hene laser to check the entire fiber length for defects prior to shipment.During the packaging step, the fibers are inspected for damage.  potential root cause is handling damage after leaving angiodynamics facility.A review of the device history records was performed for the reported packaging and component lots for any deviations related to the reported defect of the complaint.The review confirms that the lots met all material, assembly, and performance specifications.Labeling review: the directions for use which is supplied to the end user with the reported catalog number contains the following statement "the venacure evlt 400 [?]m perforator and accessory vein ablation kit is intended for use in the treatment of superficial vein reflux of the greater saphenous vein associated with varicosities.The venacure evlt 400m perforator and accessory vein ablation kit is indicated for treatment of incompetence and reflux of superficial veins in the lower extremity, and for treatment of incompetent (i.E.Refluxing) perforator veins (ipvs).Venacure evlt 400 [?]m perforator and accessory vein ablation kit: using sterile technique open the pack, place all contents into sterile field and inspect for damage.Do not use if any component is damaged.If damage is present, contact customer service or your local representative.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: 400 MICRON FIBER PROCEDURE KIT
• Type of Device: 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: 15626478
• MDR Text Key: 301938791
• Report Number: 1319211-2022-00041
• Device Sequence Number: 1
• Product Code: GEX
• UDI-Device Identifier: H787EVLTPVAK5
• UDI-Public: H787EVLTPVAK5
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K041957
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/18/2022

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
• Device Operator: Health Professional
• Device Catalogue Number: EVLTPVAK
• Device Lot Number: 5742839
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/23/2022
• Initial Date FDA Received: 10/18/2022
• Supplement Dates Manufacturer Received: 11/14/2022
• Supplement Dates FDA Received: 11/18/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/12/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1