BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PT2 GUIDE WIRE

    MDR report key: 1192123 · Received October 7, 2008

    Report

    Report Number
    2134265-2008-02943
    Event Type
    Injury
    Date Received
    October 7, 2008
    Date of Event
    September 9, 2008
    Report Date
    September 9, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    DQX
    PMA / PMN Number
    K030617
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL PRODUCT INFO: 185, STRAIGHT, 1-PACK.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTIONAL (PCI) PROCEDURE, A GUIDE WIRE TIP DETACHMENT OCCURRED. THE NON BSC IN-STENT 100% RESTENOTIC, CALCIFIED LESION WAS LOCATED IN THE SEVERLY TORTUOUS PROXIMAL RIGHT CORONARY ARTERY (RCA). THE PT2 GUIDE WIRE WAS ADVANCED TO THE MID RCA, BUT WAS NOT A "TRUE LUMEN." THEN THE DISTAL TIP WAS PROLAPSED AND FRACTURED. THE FRACTURED DISTAL TIP REMAINED IN THE PROXIMAL RIGHT CORONARY ARTERY. THE PHYSICIAN ATTEMPTED TO RETRIEVE THE DISTAL TIP WITH A SNARE DEVICE, BUT WAS UNSUCCESSFUL. THE PT2 GUIDEWIRE WAS WITHDRAWN WITHOUT RESISTANCE, AND TWO ADDITIONAL GUIDEWIRES BOTH FROM ANOTHER MANUFACTURER, WERE USED. ANOTHER MANUFACTURER'S BALLOON DILATED THE LESION, HOWEVER, THE BALLOON RUPTURED. THE PROCEDURE WAS NOT COMPLETED. THE GUIDEWIRE TIP REMAINS INSIDE THE PT. THE PATIENT'S STATUS WAS REPORTED AS "STABLE".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PT2 GUIDE WIRE DQX WIRE, GUIDE, CATHETER DQX BOSTON SCIENTIFIC MODERATE 11626726

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention TERUMO 7 FRENCH SHEATH| INTECC ASAHI X-TREME GUIDE WIRE| CONQUEST GUIDE WIRE| MEDTRONIC LAUNCHER 7 FRENCH GUIDE CATHETER| ABBOTT WHISPER GUIDE WIRE| MEDTRONIC SPRINTER 1.25 X 6MM BALLOON| MEDTRONIC EVEREST INFLATION DEVICE| TERUMO FINECROSS MICRO CATHETER| BOSTON SCIENTIFIC EXCELSIOR MICRO CATHETER