BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEXOR CHECK FLO INTRODUCER

    MDR report key: 2752241 · Received September 17, 2012

    Report

    Report Number
    2752241
    Event Type
    Injury
    Date Received
    September 17, 2012
    Date of Event
    September 7, 2012
    Report Date
    September 17, 2012
    Manufacturer
    COOK INCORPORATED
    Product Code
    OEX
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TX, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PATIENT HAD LEFT HEART CATH, RECEIVED 6F 55 CM SHEATH. UPON SHEATH EXCHANGE OVER THE WIRE, AS THE SHEATH PULLED BACK OVER THE WIRE, THE SHEATH SHEARED AND A PIECE SEPARATED FROM THE SHEATH STRUCTURE. PHYSICIAN ACCESSED THE RIGHT BRACHIAL ARTERY, PASSED A SNARE TO THE AORTA, SNARED A PIECE OF SHEATH AND PULLED BACK TO BRACHIAL ARTERY. ANOTHER PHYSICIAN THEN PERFORMED A CUTDOWN TO RETRIEVE THE SHEATH. TWO HOURS S/P LEFT HEART CATH THE PATIENT DEVELOPED EXPRESSIVE APHASIA. INITIAL CT WAS NEGATIVE FOR CHAIR. SUBSEQUENT MRI SHOWED MULTIFOCAL BILATERAL CVAS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FLEXOR CHECK FLO INTRODUCER 6F 55CM RAABE SHEATH (OEX) OEX COOK INCORPORATED G11638 3094640

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention