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	04/04/2023
Type of Reportable Event	Malfunction
Event or Problem Description
At the start of the procedure, when opening the nevertouch direct procedure kit kit, the fiber appeared as expected.When the fiber was inserted into the patient's vein, there were no noted issues.The provider started the burn, with the unit showing energy, however, the fiber was not burning as expected.The provider removed the fiber, at which time the fiber broke into three pieces.It was reported that no part of the fiber had been retained inside the patient, therefore no additional intervention was needed such as cut down or snare.The procedure was completed with another of the same device/kit.It was reported the patient did not experience any adverse effects, harm, or require medical intervention because of this incident.
Additional Manufacturer Narrative
The device is not available to be returned to the manufacturer for evaluation.The results of the investigation will be sent via a follow up medwatch.Reference (b)(4).
Additional Manufacturer Narrative
As the reported device was not returned, angiodynamics is unable to perform a device evaluation.However, the end user supplied a photograph of the fractured fiber for analysis.The customer's reported complaint of the fiber fractured and detached was confirmed based on the pictures provided by the end user.Although the complaint description was confirmed, a definitive root cause cannot be determined since the complaint sample was not returned for evaluation.The root cause of the fiber fractures and detachment cannot be confirmed based on the picture provided.A potential root cause for this type of fracture/detachment failure mode is a fracture of the fiber core due to handling damage, which allow laser energy to escape at the fracture site and eventually results in fiber detachment.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.During the manufacturing process, the disposable fiber device receives a 100% inspection and an aql inspection in which the quality of the fiber strip is inspected.Prior to packaging, all components are inspected for damage.Labeling review: the instructions for use which is supplied to the end user with this catalog number contains the following statement "avoid damaging the fiber by striking, stressing or excessive bending.Do not coil the fiber tighter than a diameter of 16cm.".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: 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 ; 5086587990
• MDR Report Key: 16832755
• Report Number: 1319211-2023-00033
• Device Sequence Number: 11245634
• Product Code: GEX
• UDI-Device Identifier: H787114031015
• UDI-Public: H787114031015
• Combination Product (Y/N): N
• Initial Reporter Country: VM
• 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: Foreign,Company Representative,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/03/2023

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
• Operator of Device: Health Professional
• Device Expiration Date: 07/31/2025
• Device Catalogue Number: 11403101
• Device Lot Number: 5743582
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/05/2023
• Supplement Date Received by Manufacturer: 04/28/2023
• Initial Report FDA Received Date: 04/28/2023
• Supplement Report FDA Received Date: 05/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/25/2022
• 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 Age: 61 YR
• Patient Sex: Female
• Patient Weight: 56 KG