BEUDAMED
    FDA Adverse Event Other Summary report: N

    VISION PV 0.018

    MDR report key: 1525471 · Received November 6, 2009

    Report

    Report Number
    2939520-2009-00028
    Event Type
    Other
    Date Received
    November 6, 2009
    Date of Event
    June 22, 2007
    Report Date
    October 28, 2009
    Manufacturer
    VOLCANO CORPORATION
    Product Code
    IYO
    PMA / PMN Number
    K944004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE CATHETER WAS ANALYZED BY MFG ENGINEERING, RESEARCH AND DEVELOPMENT, AND QUALITY. PART OF THE DISTAL TIP WAS MISSING AND WAS NOT RETURNED FOR EVAL. THE MATERIAL OF THE DISTAL TIP WAS CLEANLY SEPARATED AT THE DISTAL END OF THE TIP MARKER AND WAS SLIGHTLY FLARED OUTWARD. IT APPEARS THE SEPARATION OCCURRED WITHIN THE MATERIAL AND NOT AT THE ADHESIVE BOND. A 0.018" GUIDEWIRE WAS THREADED THROUGH THE CATHETER FROM THE SKIVE WITH NO RESISTANCE FELT. THE RETURNED PORTION OF THE CATHETER APPEARED TO HAVE BEEN MFG TO SPEC. THE IFU STATES 'DO NOT ADVANCE THE CATHETER AGAINST SIGNIFICANT RESISTANCE. IF BINDING OCCURS BETWEEN THE CATHETER AND GUIDEWIRE WHILE INSIDE THE PT, CAREFULLY REMOVE BOTH THE WIRE AND CATHETER AND DO NOT USE. IF BINDING OCCURS OUTSIDE OF THE PT, REMOVE THE CATHETER AND DO NOT USE.' WE WERE UNABLE TO DETERMINE THE REASON THE CATHETER CAUGHT ON THE WIRE SINCE NEITHER THE TIP NOR THE GUIDEWIRE WERE RETURNED. NOTE: ON (B)(6) 2009, THIS CASE WAS REASSESSED BY QUALITY MANAGEMENT. ON THAT DATE IT WAS DECIDED TO FILE A REPORT DUE TO THE POTENTIAL SAFETY AND SUBMIT IT AS A NOTIFICATION ONLY.

    Description of Event or Problem · 1

    A 0.018 GUIDEWIRE COULD NOT BE ADVANCED THROUGH A PV 0.018. THE TIP BROKE OFF OUTSIDE THE PT, SO NO PT HARM OCCURRED. ADDITIONAL INFO: A BSCI CONTROL WIRE 0.018 WAS POSITIONED IN THE FEMORAL ARTERY. PV 0.018 WAS TAKEN OUT OF THE PACKAGE, NO DAMAGE WAS NOTICED. ADVANCING THE CATHETER OVER THE WIRE, IT WAS NOTICED IT GOT STUCK RATHER SOON. THIS HAPPENED OUTSIDE THE PT. APPLYING MORE FORCE, THE CATHETER BROKE AT THE TIP. AT THE END, THE TIP WAS REMOVED FROM THE WIRE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VISION PV 0.018 INTRAVASCULAR ULTRASOUND CATHETER IYO VOLCANO CORPORATION 86700 003 01400

    Patients

    Seq Age Sex Outcome Treatment
    1