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

Model Number	11403013
Medical Device Problem Codes	Unraveled Material (1664); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	03/16/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported device has yet to be returned to the manufacturer for a device evaluation.An investigation into the root cause for product problem is currently in progress.The results of the investigation will be sent via a follow up medwatch.Reference (b)(4).
Event or Problem Description
A distributor reported an end user experienced an issue when using a guidewire from a 65cm nevertouch frs.018 procedure kit.The surgeon punctured the patient's vein and inserted the guidewire in the usual way.He struggled to advance the guidewire after a few cm's and noticed something unusual on ultrasound.He took out the access needle and slowly retracted the guidewire and as he did, he noticed the wire had unraveled.The surgeon noticed 1cm of the end of the wire had snapped off and was at the entry point on the leg.He removed this with some forceps.The surgeon decided to start again with a different venacure evlt procedure kit, and completed the procedure with no further incident.The patient did not experience any adverse effects or harm due to this incident.
Additional Manufacturer Narrative
Returned for evaluation was one (1) guidewire.The customer's reported complaint description of guidewire unraveled and tip detached is confirmed based on evaluation of the returned complaint sample.The guidewire is purchased device and the complaint sample was sent to the supplier/manufacturer, heraeus medical for sample evaluation/root cause determination and dhr review of the reported lot number.The supplier concluded that "a review of the device history records of the specimen device does not present any indication of manufacturing defect or anomaly that could have impacted on the event as reported.The history records indicate this product was final inspection tested at (b)(6) medical and was determined to be acceptable.At this time, it is not possible to assign a definitive root cause for the event as reported.Based on the information provided by the supporting documentation, "improper use", "excessive force used", and/or "improper handling" may have impacted on the event as reported." may have impacted on the event as reported." although a definitive root cause could not be determined, potential contributing factor for the guidewire tip unraveling and becoming detached is handling damage during guidewire use, e.G.Pulling guidewire back against needle when advancement is met with obstruction.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 instructions for use, which is supplied to the end user with this catalog number, states: "using standard seldinger technique gain access to the desired vein with the needle and corresponding guidewire.If applicable, use the micro-access introducer to exchange for a larger diameter wire.Advance the 4fr trè-sheath introducer, over the wire, to the treatment location.If treating the great saphenous vein, position sheath tip so that it is 1-2cm below the sapheno-femoral junction.Verify sheath positioning using ultrasound guidance.Remove the dilator and guidewire." 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 FIBER
• 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: 16683953
• Report Number: 1319211-2023-00024
• Device Sequence Number: 20862193
• Product Code: GEX
• UDI-Device Identifier: H787114030130
• UDI-Public: H787114030130
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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,User Facility,Company Representative,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/19/2023

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: 08/31/2025
• Device Model Number: 11403013
• Device Catalogue Number: 11403013
• Device Lot Number: 5749585
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/23/2023
• Supplement Date Received by Manufacturer: 06/15/2023
• Initial Report FDA Received Date: 04/05/2023
• Supplement Report FDA Received Date: 06/19/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/19/2022
• 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