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 05/19/2022

Event Type  malfunction  

Event Description

A technical director reported an issue with a pvak -- 400 micron perforator and accessory vein ablation kit.During preparation, the fiber was connected to the laser unit and light was seen coming from the middle of the fiber, indicating a fracture.When the end user touched the fiber, it "broke completely." the procedure was completed with another same device and the patient did not experience any adverse effects, harm, or require medical intervention as a result of this incident.

Manufacturer Narrative

The reported device has yet to be returned to the manufacturer for a device evaluation.An investigation into the root cause for product problem is currently in progress.The results of the investigation will be sent via a follow up medwatch.Reference (b)(4).

Manufacturer Narrative

Returned for evaluation was an evlt pvak fiber.A visual inspection noted that the fiber fracture it was located at 70.2 mm from the distal edge of the black strain relief of the gripper.During the sme evaluation, it was noted: the fiber break occurred 70.2cm from the distal end of the black strain relief, the fiber glass core at the break point is jagged and the buffer on each side of the break is distorted, there is no sign of damage to the fiber buffer layer beyond the break point and the rfid tag indicates the number of uses a"0", therefore the laser was not fired before the break was observed.The customer's reported complaint description of the fiber was fractured and detached was confirmed based on evaluation of the returned sample.Although confirmed, a definitive root cause for the fiber fracture could not be determined.Handling damage is likely root cause for the fiber fracture/detachment, however, when is occurred could not be determined.A device history records search for the indicated packaging/assembly lots revealed no quality related issues or manufacturing deficiencies at the time of manufacture.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.Labeling review: the directions for use which is supplied to the end user with this 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 ; 5086587805
• MDR Report Key: 14621133
• MDR Text Key: 295794393
• Report Number: 1319211-2022-00026
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 06/22/2022

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: 5724636
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Initial Date Manufacturer Received: 05/19/2022
• Initial Date FDA Received: 06/07/2022
• Supplement Dates Manufacturer Received: 06/21/2022
• Supplement Dates FDA Received: 06/22/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/21/2022
• 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