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 10/03/2023

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

An end user reported an issue with a pvak -- 400 micron perforator and accessory vein ablation kit.While unpacking, it was noticed that the fiber was cut in 2 places, prior to removing from the tray/package.There was no damage noted to the internal or external packaging of the device and the tray was fully sealed.The following procedure was completed with another same device and the patient did not experience any adverse effects, harm, or require medical intervention as a result of this incident.

Manufacturer Narrative

Returned for evaluation was one (1) pvak evlt fiber.The sample was returned in two pieces, with the complete break occurring at 12cm from distal end of gripper strain relief and a second break (though still attached) at 128cm from the distal tip of the fiber.The buffer was not significantly stretched or distorted at the site of either break providing initial indication that excessive stress was not placed on the fiber.The customer's reported complaint description of fiber fractured and detached was confirmed during evaluation of the returned fiber.The returned complaint sample shows the fiber was fractured.The root cause of the fracture in the fiber core cannot be definitively determined, however, potential contributing factors include material variability in fiber core and handling damage during transit/storage.Engineer investigation: it is anticipated that the fiber material has some imperfections (material variability) 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 of fractured fibers is handling damage after leaving angiodynamics facility.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: 17987551
• MDR Text Key: 326320818
• Report Number: 1319211-2023-00069
• 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: 12/06/2023

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: 5790327
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/12/2023
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/04/2023
• Initial Date FDA Received: 10/23/2023
• Supplement Dates Manufacturer Received: 12/05/2023
• Supplement Dates FDA Received: 12/06/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/27/2023
• 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