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

Catalog Number EVLTPVAK

Device Problem Fracture (1260)

Patient Problems Burn(s) (1757); Pain (1994)

Event Date 05/31/2023

Event Type  malfunction  

Manufacturer Narrative

The reported device has been returned to the manufacturer and an investigation into the root cause for event is currently in progress.The results of the investigation will be sent via a follow up medwatch.Reference (b)(4).

Event Description

The doctor was using a pvak - 400 micron fiber procedure kit to treat a patient with multiple incompetent perforators.The treatment of the first two perforator veins was successful.During treatment of the third perforator, the patient expressed complaint of burning pain.The lasing was discontinued and the needle and laser were withdrawn.Upon inspection, there was a visible burn hole several cm from the distal tip of the laser.The laser fiber was cut/sheered off at that location.The distal portion of the laser tip remained in the needle when removed; therefore, no laser fiber remnant was left in the patient.Post-op, the patient had a visible burn mark on the skin.The physician had planned a post op follow up with the patient in 2 or 3 days.One day post op note from rn - post op instructions were reviewed and patient verbalizes understanding.Questions and concerns addressed.Compression stockings were brought to the appointment, but patient rewrapped with kerlix, abds and coban.Dr.Talked with about ultrasound results and on patient's lle on her posterior lateral calf that the laser slightly burned at the puncture site.Site not bothering patient, no blistering, no signs or symptoms of infection.Patient instructed to call the office with any questions or concerns that may arise.

Manufacturer Narrative

Returned for evaluation was one (1) pvak evlt fiber and needle.A visual inspection noted that the fiber had one fracture also returned was a needle which had the distal tip of the fiber inside the needle.The needle returned shows the metal cannula having a burn mark.Upon removal of the fiber segment, the break in the glass core at the site of the fracture was observed to be clean.There was no indication of stretching or excessive stress placed on the fiber at the point of the fracture.The buffer material on each side of the break was melted indicating laser output during the break or immediately following it, further supported by burn marks on the needle aligning with the site of the fracture.The customer's reported complaint description of fiber fractured and detached was confirmed during evaluation of the returned fiber and needle complaint samples.The patient burn (minor) was also confirmed via pictures provided.The returned complaint sample shows the fiber was fractured, the needle returned shows there to be a burn mark.The root cause of the patient burn is fracture of the fiber core resulting in laser energy escaping at a location inside of the needle.This laser energy heated the needle cannula, which resulted in the minor patient burn at entry site.The root cause of the fracture in the fiber core cannot be definitively determined, however, potential contributing factors include material variability in fiber core and handling damage during use/advancement of the fiber device.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 directions for use which is supplied to the end user with the reported catalog number contains the following statement "prior to and during use, avoid damaging the fiber by striking, stressing or excessive bending.Do not coil the fiber tighter than a radius of 60mm".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 ; 5086587990
• MDR Report Key: 17184942
• MDR Text Key: 317940363
• Report Number: 1319211-2023-00038
• 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: 08/02/2023

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: 5757677
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/12/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/05/2023
• Initial Date FDA Received: 06/22/2023
• Supplement Dates Manufacturer Received: 08/02/2023
• Supplement Dates FDA Received: 08/02/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/26/2022
• 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
• Patient Age: 37 YR
• Patient Sex: Female
• Patient Weight: 69 KG