BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLEXOR

    MDR report key: 6303401 · Received February 6, 2017

    Report

    Report Number
    6303401
    Event Type
    Malfunction
    Date Received
    February 6, 2017
    Date of Event
    January 24, 2017
    Report Date
    January 30, 2017
    Manufacturer
    COOK VASCULAR INC.
    Product Code
    DYB
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    UNIQUE DEVICE IDENTIFIER (UDI): FOR TYPE OF DEVICE: INTRODUCER, CATHETER.

    Description of Event or Problem · 1

    WHEN ADVANCING THE SHEATH OVER THE GLIDE WIRE, SIGNIFICANT RESISTANCE WAS MET. THE SHEATH WAS REMOVED AND IT WAS NOTED THAT THE DISTAL TIP OF THE SHEATH HAD TORN OFF AND WAS RETAINED IN THE BRACHIAL ARTERY. AN ATTEMPT WAS MADE AT SNARING THE RETAINED FRAGMENT BUT WAS UNSUCCESSFUL SO THE PATIENT WAS TAKEN TO THE OR FOR REMOVAL.

    Description of Event or Problem · 1

    WHEN ADVANCING THE SHEATH OVER THE GLIDE WIRE, SIGNIFICANT RESISTANCE WAS MET. THE SHEATH WAS REMOVED AND IT WAS NOTED THAT THE DISTAL TIP OF THE SHEATH HAD TORN OFF AND WAS RETAINED IN THE BRACHIAL ARTERY. AN ATTEMPT WAS MADE AT SNARING THE RETAINED FRAGMENT BUT WAS UNSUCCESSFUL SO THE PATIENT WAS TAKEN TO THE OR FOR REMOVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    87777 FLEXOR INTRODUCER, CATHETER DYB COOK VASCULAR INC. G12266 7478767

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Other NO