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 10/18/2022

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

An end user reported an issue with a pvak -- 400 micron perforator and accessory vein ablation kit.During preparation, after plugging in the fiber into a 1470 pro laser, the customer began to unravel the fiber.They noticed the aiming beam coming out of the fiber, about 4 inches from the tip; therefore, there was a concern that there could be a break in the fiber so the procedure was completed with another same device.The patient did not experience any adverse effects, harm, or require medical intervention as a result of this incident.The angiodynmics representative for this customer confirmed that the fiber is cracked/fractured.

Manufacturer Narrative

Returned for evaluation was one (1) pvak evlt fiber.A visual inspection noted that the fiber had one fracture; it was located at 17.7cm from the distal tip.The customer's reported complaint that aiming beam was coming out of the fiber 4 inches from the fiber tip was confirmed.Evaluation of the fiber showed a scrape of the fiber at this location (4 inches from tip), which coincides with video provided by customer.The fiber fracture as received, was deemed to be handling damage during return shipping and not part of the customer's reported complaint event.Although the complaint is confirmed for aiming beam escaping 4 inches from tip, a definitive root cause for the scrape in the fiber shaft cannot be determined.The most likely root cause is some sort of handling damage, but how/when this occurred cannot be determined.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.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.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 400m 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: 15734376
• MDR Text Key: 304631898
• Report Number: 1319211-2022-00047
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 11/10/2022

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/31/2022
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/18/2022
• Initial Date FDA Received: 11/04/2022
• Supplement Dates Manufacturer Received: 11/08/2022
• Supplement Dates FDA Received: 11/10/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/12/2022
• 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