MAUDE Adverse Event Report: ANGIODYNAMICS VENACURE NEVERTOUCH DIRECT PROCEDURE KIT; VENACURE ENDOVENOUS LASER TREATMENT FIBER

Catalog Number	11403101
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/25/2022
Type of Reportable Event	Malfunction
Event or Problem Description
An end user reported an issue with a pvak -- 400 micron perforator fiber.When the physician attempted to insert the fiber into the machine, it broke in half.A new fiber was opened to complete the procedure.The patient did not experience any adverse effects, harm, or require medical intervention because of this incident.
Additional 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).
Additional Manufacturer Narrative
Returned for evaluation was a fiber noted to be coiled and in 2 pieces.A visual inspection noted that the fiber fracture it was located at 46.7cm from the distal end of the fiber shaft.The break point in the fiber glass core is not jagged and the break appears to have occurred under a low stress condition.Since the beak appears to have occurred under a low stress condition, the stretched / distorted buffer on one side of the break is most likely due to handling after the break occurred.The customer's reported complaint description of" the physician attempted to insert the fiber into the machine, it broke in half" was confirmed based on evaluation of the returned fiber sample.Although confirmed, a definitive root cause for the fiber fracture could not be determined.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.There is no way to definitively determine what exactly caused the break but it is possible that bending of the fiber when being connected to a laser in combination with some material variability in the fiber glass core may have resulted in the break that occurred.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 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 pr(b)(6).

• Brand Name: VENACURE NEVERTOUCH DIRECT PROCEDURE KIT
• Common Device Name: 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: 15173499
• Report Number: 1319211-2022-00033
• Device Sequence Number: 6213043
• Product Code: GEX
• UDI-Device Identifier: H787114031015
• UDI-Public: H787114031015
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K171921
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/26/2022

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
• Operator of Device: Health Professional
• Device Expiration Date: 02/28/2025
• Device Catalogue Number: 11403101
• Device Lot Number: 5723653
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/28/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/25/2022
• Supplement Date Received by Manufacturer: 08/24/2022
• Initial Report FDA Received Date: 08/05/2022
• Supplement Report FDA Received Date: 08/26/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/15/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown