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 08/22/2022

Event Type  malfunction  

Event Description

An end user reported, via voicemail, that a fiber from a pvak -- 400 micron fiber procedure kit fractured.When they were setting up for a procedure, they were removing the white plastic from around the fiber, and in doing so the fiber snapped in half.There was no patient contact or involvement.The whole kit along with the fiber were put to the side and new kit/fiber was opened for the procedure.The procedure was completed with no issues.

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 139cm from the distal tip.The customer's reported complaint description of fiber fractured was confirmed.Based on the reported complaint description the root cause for the fiber fracture is likely handling damage by end user when removing spiral wrap from the fiber coils.As indicated in the information provided, this issue was noted when unpacking the fiber assembly.What most likely occurred is that when removing the spiral wrap which secures the fiber in a coiled configuration, an excessive amount of force was applied to fiber which resulted in the break.Since this particular fiber assembly has a small 400-micron core, it can be susceptible to damage if not handled correctly and a degree of caution is required when removing the plastic spiral wrap to avoid damaging the fiber.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.Potential root cause is handling damage after leaving angiodynamics facility.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 ; 5086587805
• MDR Report Key: 15538826
• MDR Text Key: 301582240
• Report Number: 1319211-2022-00040
• 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
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 10/04/2022

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: 5719839
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/27/2022
• Initial Date Manufacturer Received: 09/14/2022
• Initial Date FDA Received: 10/04/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/22/2022
• 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