BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RADIFOCUS PINNACLE CATHETER (BOSTON SCIENTIFIC)

    MDR report key: 82759 · Received August 15, 1994

    Report

    Report Number
    82759
    Event Type
    Injury
    Date Received
    August 15, 1994
    Date of Event
    May 11, 1994
    Report Date
    May 27, 1994
    Manufacturer
    MFR BY: TERUMO CORP
    Product Code
    DYB
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TN, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    FOLLOWING CARDIAC CATHETERIZATION WHILE WITHDRAWING THE GUIDEWIRE, IT UNCOILED AND A 2 CM. TIP OF THE GUIDEWIRE REMAINED IN THE FEMORAL ARTERY. DETACHED TIP OF GUIDEWIRE WAS REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RADIFOCUS PINNACLE CATHETER (BOSTON SCIENTIFIC) INTRODUCER B KIT DYB MFR BY: TERUMO CORP RF SB7011P 8893I30

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention INTRODUCER SHEATH| CORNON NEEDLE