BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CORDIS

    MDR report key: 175282 · Received July 2, 1998

    Report

    Report Number
    175282
    Event Type
    Injury
    Date Received
    July 2, 1998
    Date of Event
    April 9, 1998
    Report Date
    May 26, 1998
    Manufacturer
    CORDIS CORPORATION
    Product Code
    LOX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    AFTER A ROUTINE CATHETERIZATION PROCEDURE, A 7F HIGH-FLOW JLS GUIDING CATHETER WAS INSERTED FOR PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY. WHILE TORQUING THE CATHETER IN ATTEMPTING TO ENGAGE THE LEFT CORONARY ARTERY, THE CATHETER BECAME KINKED, AND BROKE INTO PIECES. THE DISTAL HALF OF THE CATHETER WAS LEFT IN THE DESCENDING AORTA. A 10 MM SNARE WAS INTRODUCED VIA THE 7F SHEATH IN THE RIGHT GROIN AND THE DISTAL END OF THE CATHETER WAS SNARED. ATTEMPTS TO PULL THE CATHETER INTO THE 7F GUIDE SHEATH WAS UNSUCCESSFUL, AND THE SHEATH COULD BE FELT TO CRIMP AND BUCKLE UNDER THE PRESSURE. THEREFORE, THE SNARE WAS REMOVED FROM THE DISTAL PORTION OF THE CATHETER IN THE AORTA AND REMOVED, THE 7F SHEATH WAS REPLACED WITH A 8F SHEATH. THE DISTAL END OF THE CATHETER WAS AGAIN SNARED SECURELY AND PULLED INTO THE DISTAL PORTION OF THE 8F SHEATH, AND THEN BOTH THE SHEATH AND THE CATHETER WERE REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CORDIS 7F JL5 GUIDING CATHETER LOX CORDIS CORPORATION * 40298244

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Required Intervention