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 08/24/2023

Event Type  malfunction  

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).

Event Description

A territory manager reported an end user experienced an issue when using a fiber from a pvak -- 400 micron perforator and accessory vein ablation kit.During a procedure, the laser fiber in one of the kits was plugged in and "nothing happened." the end user used another of the same product to complete the procedure.The patient did not experience any adverse effects, harm, or require medical intervention because of this incident.After the procedure was completed, the original fiber was inspected and found to have a bent shaft (fractured).

Manufacturer Narrative

Returned for evaluation was a pvak evlt fiber.The returned fiber was noted to be fractured and detached, with the break occurring 96cm from the distal tip.The buffer had stretched/distorted, probably post procedure as the complaint form indicated a bend in the fiber - implying it was still attached.Once the buffer layer was removed to expose core, the core was found to broken flat and cleanly (not evidence of severe stress).There were no obvious manufacturing defects observed.Fiber assemblies are 100% beam shape tested in final assembly stages, indicating the lowlihood of the failure occurring after that inspection.The fiber returned was plugged into the tagwrite and shows that the fiber was fired/used.Engineer investigation: it is anticipated that the fiber material may have some imperfections in the glass core which can impact the resultant fiber strength.To detect imperfections that will not withstand the minimum stress expectations, the fiber material is subjected to an in-process stress test when produced by the vendor.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.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 was fractured and detached 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 damage to the fiber device during shipping/transit/unpacking/device use.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 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.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: 17700516
• MDR Text Key: 322863955
• Report Number: 1319211-2023-00054
• 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: 11/08/2023

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: 5776678
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/30/2023
• Initial Date FDA Received: 09/07/2023
• Supplement Dates Manufacturer Received: 11/07/2023
• Supplement Dates FDA Received: 11/08/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/21/2023
• 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: 48 YR
• Patient Sex: Female
• Patient Weight: 87 KG