BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VENACURE NEVERTOUCH

    MDR report key: 2974136 · Received February 12, 2013

    Report

    Report Number
    1319211-2013-00013
    Event Type
    Injury
    Date Received
    February 12, 2013
    Date of Event
    January 25, 2013
    Report Date
    January 24, 2013
    Manufacturer
    ANGIODYNAMICS
    Product Code
    GEX
    PMA / PMN Number
    K031233
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED DEFECTIVE DEVICE HAS YET TO BE RETURNED TO THE MFR FOR A DEVICE EVALUATION. THE FIRM IS ATTEMPTING TO OBTAIN THE DEVICE. AN INVESTIGATION INTO THE ROOT CAUSE FOR PRODUCT PROBLEM IS CURRENTLY IN PROGRESS. THE RESULTS OF THE DEVICE EVALUATION WILL BE SENT VIA A FOLLOW UP MEDWATCH. A REVIEW OF THE LOT HISTORY RECORDS FOR THE REPORTED LOT WAS PERFORMED FOR ANY DEVIATIONS. THE REVIEW CONFIRMS THAT THE LOTS MET ALL MATERIAL, ASSEMBLY, AND PERFORMANCE SPECIFICATIONS. ANGIODYNAMICS IS ATTEMPTING TO OBTAIN PT INFO IN REGARDS TO THE SCHEDULED PROCEDURE TO REMOVE THE FRACTURED TRE-SHEATH PIECE. A REVIEW OF THE ANGIODYNAMICS COMPLAINT SYSTEM NOTED NO TRENDS FOR THIS COMPLAINT TYPE AND PRODUCT FAMILY. THIS TYPE OF COMPLAINT WILL CONTINUE TO BE MONITORED FOR TRENDS. (B)(4).

    Description of Event or Problem · 1

    AS REPORTED, (B)(6) 2013, A MALE PT OF UNK AGE PRESENTED FOR AN ENDOVENOUS LASER TREATMENT. DURING THE PROCEDURE, WHEN THE TREATING PHYSICIAN WAS INSERTING THE FIBER INTO THE TRE-SHEATH DILATOR, IT WAS NOTED THAT APPROXIMATELY 1CM OF THE DISTAL TIP OF THE TRE-SHEATH DILATOR HAD FRACTURED INSIDE THE PT. IT WAS REPORTED THE TRE-SHEATH DID NOT APPEAR TO BE BURNT. THE PROCEDURE WAS CONTINUED AND SUCCESSFULLY COMPLETED. A SECOND PROCEDURE WAS SCHEDULED FOR THE PT TO HAVE THE FRACTURED PIECE OF THE TRE-SHEATH DILATOR RETRIEVED. IT WAS REPORTED THE DISPOSABLE DEVICE IS AVAILABLE FOR RETURN TO THE MANUFACTURER FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    62146 VENACURE NEVERTOUCH ENDOVENOUS LASER TREATMENT FIBER GEX ANGIODYNAMICS 587367

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention