MAUDE Adverse Event Report: ANGIODYNAMICS 400 MICRON FIBER PROCEDURE KIT; VENACURE ENDOVENOUS LASER TREATMENT FIBER

Catalog Number EVLTPVAK

Device Problem Fracture (1260)

Patient Problem Foreign Body In Patient (2687)

Event Date 06/10/2022

Event Type  malfunction  

Manufacturer Narrative

Returned for evaluation was an evlt fiber.A visual inspection noted that the fiber fracture it was located at 26.6cm from the fiber tip.Since the break was confined to a localized point along the fiber and there was no apparent buffer damage beyond the break point, general mishandling does not appear to be associated with the break.The 400-micron fiber material is somewhat fragile due to its size and a degree of caution must be taken when handling an evlt pvak fiber assembly.Most likely either material variability or the fiber being accidentally pinched is associated with the break.There is no way to definitively determine what the exact root cause of the break was, but it appears to have resulted when a low level of stress was being exerted on the fiber material.The customer's reported complaint description of the fiber was fractured and detached was confirmed based on evaluation of the returned sample.The fiber became fractured during use of the device; handling damage (e.G.Pinching of fiber) from a low level of stress being exerted on the fiber material is likely root cause.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.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).

Event Description

It was reported that the fiber from a pvak -- 400 micron perforator and accessory vein ablation kit broke during the procedure.The physician was able to remove the fiber from the patient and 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.

• 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: 14798861
• MDR Text Key: 295794422
• Report Number: 1319211-2022-00030
• 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: User Facility,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 06/24/2022

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: 5720779
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/16/2022
• Initial Date Manufacturer Received: 06/13/2022
• Initial Date FDA Received: 06/24/2022
• Was Device Evaluated by Manufacturer?: Yes
• 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