BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VERRATA PRESSURE GUIDEWIRE

    MDR report key: 4127739 · Received September 24, 2014

    Report

    Report Number
    2939520-2014-00079
    Event Type
    Malfunction
    Date Received
    September 24, 2014
    Date of Event
    August 20, 2014
    Report Date
    August 26, 2014
    Manufacturer
    VOLCANO CORPORATION
    Product Code
    DQX
    PMA / PMN Number
    K131288
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE MANUFACTURING DOCUMENTATION FOR THIS DEVICE WAS REVIEWED AND THE DEVICE MET ALL QUALITY AND MANUFACTURING RELEASE CRITERIA. TO DATE, NO OTHER COMPLAINTS HAVE BEEN REPORTED FOR THIS FAILURE MODE WITHIN THIS LOT. THE DEVICE WAS RETURNED AND INVESTIGATED IN ACCORDANCE WITH VOLCANO POLICY. THE BALLOON CATHETER WAS ALSO RETURNED TO VOLCANO. DURING DEVICE EVALUATION IT WAS OBSERVED THAT THE WIRE WAS KINKED AT MULTIPLE LOCATIONS; HOWEVER, THERE WERE NO OTHER NOTED VISUAL DEFECTS. AN ELECTRICAL RESISTANCE TEST WAS PERFORMED TO FIND ANY OPEN AND/OR SHORTS IN THE ELECTRICAL CIRCUIT OF THE DEVICE AND THE TEST REVEALED THAT ALL THREE CONDUCTIVE BANDS HAD RESISTANCE VALUES WITHIN SPECIFICATION. WHEN FUNCTIONALLY TESTED, THE WIRE WAS RECOGNIZED AND SUCCESSFULLY ZEROED WITHOUT ENCOUNTERING ANY ERROR MESSAGES. A STABLE PRESSURE SIGNAL WAS PRODUCED. VOLCANO IS RETURNING THE BALLOON CATHETER TO THE MANUFACTURER FOR THEIR EVALUATION. THERE IS NO INDICATION THAT THE VOLCANO DEVICE MALFUNCTIONED OR CONTRIBUTED TO THIS EVENT, AND NO PATIENT INJURY WAS REPORTED; HOWEVER WE WILL CONTINUE TO MONITOR COMPLAINT INFORMATION FOR VERRATA PRODUCTS PER OUR STANDARD PROCESS. NO ADDITIONAL INVESTIGATION IS PLANNED.

    Description of Event or Problem · 1

    USER REPORTS THAT THE VERRATA WIRE AND A BALLOON CATHETER (NOT A VOLCANO CORP. PRODUCT) WERE OPENED AND PREPARED ACCORDING TO THEIR RESPECTIVE IFU'S. DURING THE PROCEDURE THE BALLOON CATHETER SCRATCHED ON THE WIRE AND BECAME STUCK. UPON RETRIEVAL, THE BALLOON HAD BROKEN INTO TWO PIECES. ADDITIONAL INFORMATION OBTAINED FROM THE CUSTOMER INDICATED THAT NO DAMAGE WAS OBSERVED ON THE VERRATA DEVICE DURING PREPARATION AND ALL PORTIONS OF THE WIRE WERE ACCOUNTED FOR WHEN REMOVED FROM THE PATIENT. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL WITH NO REPORTED INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    593396 VERRATA PRESSURE GUIDEWIRE WIRE, GUIDE, CATHETER DQX VOLCANO CORPORATION 10185 0243 20026746 056

    Patients

    Seq Age Sex Outcome Treatment
    1 BOSTON SCIENTIFIC - MAVERICK BALLOON CATHETER