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

Catalog Number	EVLTPVAKUS
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/21/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported defective device has been returned to the manufacturer and an investigation into the root cause for event is currently in progress.The results of the device evaluation will be sent via a follow up medwatch.Reference (b)(4).
Event or Problem Description
An end user reported an issue with a pvak 400 micron perforator and accessory vein ablation.During unpacking, the customer noted that the catheter was broken.The device was set aside and a new of the same device was used to complete the procedure.There was no patient involvement reported by the end user.The reported device has been returned to the manufacturer and an investigation into the root cause for event is currently in progress.
Additional Manufacturer Narrative
Returned for evaluation was a 400 micron pvak fiber.A visual examination of the returned fiber confirmed the fiber was fractured as reported by the end user.The root cause of the fracture was determined to be user technique when removing the spiral wrap that secures/protects the fiber distal tip resulted in an excessive amount of force being applied to fiber which resulted in the break.Possibly the fiber was pinched with excessive force when removing the spiral wrap.The customer's reported complaint description is confirmed, there was damage to the fiber observed near the tip.Although the complaint was confirmed a definitive root cause for the fiber damage cannot be definitely determined.Handling damage 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.During the packaging step, the fibers are inspected for damage.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
• Common Device Name: VENACURE ENDOVENOUS LASER TREATMENT FIBER
• Manufacturer (Section D): ANGIODYNAMICS; 603 queensbury avenue; queensbury NY 12804
• MDR Report Key: 10815792
• Report Number: 1319211-2020-00076
• Device Sequence Number: 16619839
• Product Code: GEX
• UDI-Device Identifier: H787EVLTPVAKUS5
• UDI-Public: H787EVLTPVAKUS5
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K041957
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/23/2020

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
• Operator of Device: Health Professional
• Device Expiration Date: 08/31/2023
• Device Catalogue Number: EVLTPVAKUS
• Device Lot Number: 5626985
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/02/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/22/2020
• Supplement Date Received by Manufacturer: 10/22/2020
• Initial Report FDA Received Date: 11/10/2020
• Supplement Report FDA Received Date: 11/23/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1