BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VERRATA PRESSURE GUIDE WIRE

    MDR report key: 4890900 · Received July 1, 2015

    Report

    Report Number
    2939520-2015-00040
    Event Type
    Malfunction
    Date Received
    July 1, 2015
    Date of Event
    December 2, 2014
    Report Date
    December 2, 2014
    Manufacturer
    VOLCANO CORPORATION
    Product Code
    DQX
    PMA / PMN Number
    K131288
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS CASE WAS REVIEWED AND INVESTIGATED ACCORDING TO VOLCANO POLICY. VISUAL AND MICROSCOPIC INSPECTIONS WERE PERFORMED ON THE RETURNED DEVICE. A PLASTIC SLEEVE WAS FOUND ON THE DISTAL END OF THE WIRE THAT COVERED THE SENSOR HOUSING AND CONTINUED ALONG THE LENGTH OF THE DISTAL COIL. THE SLEEVE IS USED DURING THE MANUFACTURING PROCESS AND WAS NOT REMOVED. THE MANUFACTURING DOCUMENTATION FOR THIS DEVICE WAS REVIEWED AND THE DEVICE MET ALL QUALITY AND MANUFACTURING RELEASE CRITERIA. THERE WERE NO NONCONFORMING MATERIAL REPORTS OR DEVIATIONS NOTED THAT WOULD CONTRIBUTE TO THE REPORTED FAILURE MODE. TO DATE, NO OTHER COMPLAINTS WERE REPORTED FOR THIS SAME FAILURE MODE WITHIN THIS LOT. WE WILL CONTINUE TO MONITOR THESE TYPES OF COMPLAINTS VIA COMPLAINT REVIEW MEETINGS AND TREND DATA.

    Description of Event or Problem · 1

    DURING THE OPERATION CHECK, PRIOR TO INSERTION IN THE ARTERY, THE WIRE COULD ZERO, BUT THE USER FOUND THE TIP COIL WAS MISSING. ANOTHER SAME PRODUCT WAS USED AND THE PROCEDURE WAS COMPLETED. DEVICE WAS NOT USED IN THE PATIENT PROCEDURE; THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    429622 VERRATA PRESSURE GUIDE WIRE WIRE, GUIDE, CATHETER DQX VOLCANO CORPORATION 10185 024350028497

    Patients

    Seq Age Sex Outcome Treatment
    1