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

Model Number	11403006
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/24/2020
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 investigation will be sent via a follow up medwatch.Complaint reference (b)(4).
Event or Problem Description
Nevertouch fiber, event #2.An angiodynamics territory manager reported an issue with an evlt fiber 65cm kit.The gold jacket was caught in the end of the tre-sheath and came off when the fibre was pulled out of the patient.The reported device has been returned to the manufacturer and an investigation into the root cause for event is currently in progress.It was reported the procedure was successfully completed with no report of patient complication.
Additional Manufacturer Narrative
Returned for evaluation was a fiber, tre-sheath and dilator.A visual review of the fiber noted that the attached gold tip tube had dried blood.The returned tre-sheath was noted to be returned into two separate pieces and the dilator was returned with a kink 34.1 cm of the dilator shaft.The visual inspection of the returned sample indicated an intact fiber, dilator and guidewire.The tip of both the fiber and sheath were deemed to be properly formed and in dimensional compliance.An attempt to pass the fiber through the sheath was performed successfully without issue.The complaint as written could not be confirmed.The customer's reported complaint description was not confirmed.A root cause for the reported event cannot be determined.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.Labeling review: the instructions 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 diameter of 20cm" and "pull the sheath back and lock it to the sheath-lok fitting." the user manual (man/31/0075 us), which is supplied to the end user with this unit, states "before using a fiber, check it carefully for any signs of damage during storage or transit.Protective caps should be in place over sma connectors.Do not use if there is any sign of damage." 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
• MDR Report Key: 10387991
• Report Number: 1319211-2020-00055
• Device Sequence Number: 2813754
• Product Code: GEX
• UDI-Device Identifier: H787114030060
• UDI-Public: H787114030060
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K171921
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/06/2020

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: 02/28/2023
• Device Model Number: 11403006
• Device Catalogue Number: 11403006
• Device Lot Number: 5579177
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/10/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/24/2020
• Supplement Date Received by Manufacturer: 07/24/2020
• Initial Report FDA Received Date: 08/10/2020
• Supplement Report FDA Received Date: 10/06/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1