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 03/28/2023

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

When opening a pvak -- 400 micron fiber procedure kit for a procedure, it was noted the fiber was broken.A new of the same device was opened and used to complete the procedure.The patient did not experience any adverse effects, harm, or require medical intervention because of this incident.

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 39mm from the distal tip.Engineer investigation: it is anticipated that there may be some material variability in the fiber glass core which can impact the resultant fiber strength.All fiber material is subjected to an in-process stress test when produced by the vendor to ensure the fiber material can withstand a minimum amount of stress regardless of any material variability.When packaged, the fiber assemblies are coiled to a specific diameter to ensure any stress due to the coiled configuration is not excessive and should not adversely affect the strength of the fiber assembly for its labelled shelf life.This break appears to have occurred under a low level of stress and there are no obvious signs of any mishandling that could have contributed to the failure.It is believed the root cause of this break is most likely due to material variability in the fiber glass core which resulted in a fracture while the fiber was packaged in a coiled configuration which does place a degree of stress on the fiber core.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.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 due to a material variability in the fiber glass core and handling of fiber device during shipping/transit/unpacking.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: 16771831
• MDR Text Key: 313818223
• Report Number: 1319211-2023-00032
• 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: 05/03/2023

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: 5761781
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/13/2023
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/28/2023
• Initial Date FDA Received: 04/19/2023
• Supplement Dates Manufacturer Received: 04/28/2023
• Supplement Dates FDA Received: 05/03/2023
• 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