BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANSEL SHEATH

    MDR report key: 3652622 · Received February 14, 2014

    Report

    Report Number
    3652622
    Event Type
    Malfunction
    Date Received
    February 14, 2014
    Date of Event
    January 6, 2013
    Report Date
    February 14, 2014
    Manufacturer
    COOK MEDICAL
    Product Code
    DYB
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IL, US

    Narratives

    Description of Event or Problem · 1

    SHEATH WAS PLACED INTO PATIENT'S LEFT FEMORAL ARTERY. UPON PULLING SHEATH BACK, SHEATH WAS SUCKED BACK INTO THE PATIENT. DOCTOR PULLED SHEATH OUT. PRESSURE WAS HELD AND PATIENT DID NOT HAVE ANY HEMATOMA OR PROBLEM.====================== MANUFACTURER RESPONSE FOR 6F X 45CM ANSEL 1 SHEATH, 6F X 45CM ANSEL 1 SHEATH (PER SITE REPORTER).====================== PROVIDED NEW DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    96912 ANSEL SHEATH INTRODUCER, CATHETER DYB COOK MEDICAL * 4455755

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR