BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMAGER II

    MDR report key: 1213960 · Received October 28, 2008

    Report

    Report Number
    2134265-2008-03497
    Event Type
    Injury
    Date Received
    October 28, 2008
    Date of Event
    September 29, 2008
    Report Date
    September 29, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    DQO
    PMA / PMN Number
    K050863
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A CRYOPLASTY AND PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) PROCEDURE, A TIP DETACHMENT OCCURRED. IT WAS NOTED THAT STANDARD PTA WAS ONLY UTILIZED FOR PRE-DILATATION OF LESION. THE SEVERELY CALCIFIED LESION WAS LOCATED IN THE MILDLY TORTUOUS RIGHT SUPERFICIAL FEMORAL ARTERY (RSFA). CONTRA-LATERAL ACCESS WAS OBTAINED VIA THE LEFT FEMORAL ARTERY (LFA). AN UNSPECIFIED GUIDE WIRE WAS ADVANCED TO THE LESION. THE IMAGER II ANGIOGRAPHIC CATHETER WAS ADVANCED OVER THE ILIAC BIFURCATION TO THE SFA. THE PHYSICIAN ATTEMPTED TO ADVANCE ANOTHER UNSPECIFIED GUIDE WIRE, HOWEVER, RESISTANCE WAS ENCOUNTERED. THE PHYSICIAN ATTEMPTED TO REMOVE THE IMAGER II CATHETER, HOWEVER, THE CATHETER "WAS STUCK". UPON "PULLING HARD" ON THE IMAGER II CATHETER, APPROX 10 CM OF THE DISTAL TIP DETACHED AND REMAINED "SUPERIOR TO THE LESION". THE PHYSICIAN PERFORMED A CUT-DOWN AND WAS ABLE TO SUCCESSFULLY REMOVE THE DETACHED DISTAL TIP WITH A GOOSENECK SNARE. THE PROCEDURE WAS COMPLETED UTILIZING CROPLASTY THERAPY "WITH GOOD RESULTS". THE PT STATUS IS REPORTED AS "FINE".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IMAGER II DQO CATHETER, INTRAVASCULAR, DIAGNOSTIC DQO BOSTON SCIENTIFIC NA 0000045254

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Required Intervention