BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FATHOM? -16

    MDR report key: 3123028 · Received May 21, 2013

    Report

    Report Number
    2134265-2013-03428
    Event Type
    Malfunction
    Date Received
    May 21, 2013
    Report Date
    April 25, 2013
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    DQX
    PMA / PMN Number
    K050964
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SE
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE FATHOM GUIDEWIRE WAS RECEIVED INSIDE A CARRIER TUBE (HOOP). THE NITINOL SLEEVE, COIL WIRE AND CORE WIRE WERE FRACTURED. THE NITINOL SLEEVE WAS FRACTURED 6.25IN FROM THE ADHESIVE RAMP. THE FRACTURED END OF THE NITINOL SLEEVE EXHIBITED TORSIONAL DAMAGE. THE COREWIRE WAS FRACTURED 6.25IN FROM THE ADHESIVE RAMP. THE CORE WIRE FRACTURE SURFACE WAS BENT, INDICATING THAT THE FRACTURE MAY BE ATTRIBUTABLE TO DUCTILE BEND OVERLOAD. THE COIL WIRE WAS UNRAVELED, STRETCHED AND FRACTURED. MAGNIFIED INSPECTION OF THE FRACTURED ENDS OF THE NITINOL SLEEVE, CORE WIRE AND COIL WIRE CONFIRMED THERE WAS NO EVIDENCE OF ANY MATERIAL OR MANUFACTURING DEFICIENCIES. THE BATCH NUMBER IS UNKNOWN; THEREFORE THE MANUFACTURING RECORDS FOR THE COMPLAINT DEVICE CANNOT BE REVIEWED. THE MOST PROBABLE ROOT CAUSE IS OPERATIONAL CONTEXT AS DEVICE PERFORMANCE WAS LIMITED DUE TO ANATOMICAL AND/OR PROCEDURAL FACTORS. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A TRANSCATHETER ARTERIAL CHEMOEMBOLIZATION (TACE) PROCEDURE, A DETACHMENT OCCURRED. THE PHYSICIAN WAS ATTEMPTING TO ACCESS THE LIVER WITH A .016 -140X25CM FATHOM GUIDEWIRE. WHILE PUSHING THE GUIDEWIRE; OUTSIDE THE RENEGADE MICROCATHETER APPROXIMATELY 1CM, RESISTANCE WAS ENCOUNTERED AND THE GUIDEWIRE GOT STUCK. THE GUIDEWIRE WAS UNABLE TO BE WITHDRAWN, SO THE MICROCATHETER AND GUIDEWIRE WERE REMOVED AS ONE UNIT. THE GUIDEWIRE GOT STRETCHED OUT AND ONE PIECE FELL OFF INSIDE THE MICROCATHETER. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS STABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A TRANSCATHETER ARTERIAL CHEMOEMBOLIZATION (TACE) PROCEDURE, A DETACHMENT OCCURRED. THE PHYSICIAN WAS ATTEMPTING TO ACCESS THE LIVER WITH A .016 -140X25CM FATHOM GUIDEWIRE. WHILE PUSHING THE GUIDEWIRE; OUTSIDE THE RENEGADE MICROCATHETER APPROXIMATELY 1CM, RESISTANCE WAS ENCOUNTERED AND THE GUIDEWIRE GOT STUCK. THE GUIDEWIRE WAS UNABLE TO BE WITHDRAWN, SO THE MICROCATHETER AND GUIDEWIRE WERE REMOVED AS ONE UNIT. THE GUIDEWIRE GOT STRETCHED OUT AND ONE PIECE FELL OFF INSIDE THE MICROCATHETER. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    224669 FATHOM? -16 WIRE, GUIDE, CATHETER DQX BOSTON SCIENTIFIC - MAPLE GROVE M001509000

    Patients

    Seq Age Sex Outcome Treatment
    1 RENEGADE MICROCATHETER