BEUDAMED
    FDA Adverse Event Other Summary report: N

    PRIMEWIRE

    MDR report key: 1523110 · Received November 4, 2009

    Report

    Report Number
    2939520-2009-00030
    Event Type
    Other
    Date Received
    November 4, 2009
    Date of Event
    October 5, 2009
    Report Date
    October 5, 2009
    Manufacturer
    VOLCANO CORPORATION
    Product Code
    DXO
    PMA / PMN Number
    K070487
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT VISUAL INSPECTION SHOWED THAT ONLY 72.5 CM PROXIMAL END SECTION OF THE WIRE WAS RETURNED. THIS SECTION WAS RETURNED WRAPPED INTO A COIL FORM. MULTIPLE KINKS WERE OBSERVED ON THE RETURNED WIRE. THE REMAINING 112.5 CM DISTAL END OF THE WIRE WAS NOT RETURNED. THIS END INCLUDES HYPOTUBE, PROXIMAL COIL, SENSOR HOUSING, PRESSURE SENSOR, DISTAL TIP COIL, SCREW TIP AND DOME. BASED UPON THE ABOVE INFORMATION, THE LIKELY ROOT CAUSE OF THE ORIGINAL COMPLAINT OF "BROKEN WIRE" WAS DUE TO USER ERROR. THIS IS SUPPORTED BY THE FACT THAT THE USER INDICATED THAT THEY TRIED TO STRAIGHTEN A KINK IN THE WIRE THEN USED THE WIRE. THE WIRE WILL BE WEAKER AT THE KINK LOCATION AND THE BREAK MOST LIKELY OCCURRED AT THE KINK LOCATION. THE IFU INSTRUCTS THE USER TO NOT USE A DAMAGED WIRE. ALTHOUGH THERE WAS NO PATIENT IMPACT DUE TO THIS INCIDENT, THERE IS A POTENTIAL FOR INJURY SHOULD THIS HAPPEN AGAIN. THIS REPORT IS BEING SENT AS A NOTIFICATION. (B)(4).

    Description of Event or Problem · 1

    THE PRIMEWIRE WAS USED FOR THE INITIAL FFR WHICH DETERMINED THE LESION TO BE SIGNIFICANT. THE WIRE WAS TO BE USED FOR THE INTERVENTION AT WHICH TIME IT BECAME KINKED OUTSIDE THE PATIENT'S BODY. THE DOCTOR AND TECH TRIED TO STRAIGHTEN IT OUT, THOUGHT THEY HAD SUCCEEDED AND LOADED THE BALLOON CATHETER ON THE WIRE. ONCE ANGIOGRAPHY WAS COMPLETED, THE WIRE BROKE DURING THE EXCHANGE OF THE BALLOON CATHETER AT THE KINK LOCATION OUTSIDE THE PATIENT BODY. THE PHYSICIAN REMOVED THE WIRE FROM THE PATIENT AND A NEW GUIDEWIRE WAS USED IN PLACE OF THE FFR WIRE. GUIDE CATHETER POSITION WAS NOT LOST. THE KINKED LOCATION WAS REPORTED TO BE CLOSE TO THE CONNECTOR END OF THE WIRE AT A LOCATION NOT LIKELY TO ENTER THE PATIENT'S BODY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRIMEWIRE TRANSDUCER, PRESSURE, CATHETER TIP DXO VOLCANO CORPORATION 7903J 121 01375

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Other