BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEXOR RAABE GUIDING SHEATH

    MDR report key: 3911645 · Received June 27, 2014

    Report

    Report Number
    1820334-2014-00270
    Event Type
    Injury
    Date Received
    June 27, 2014
    Date of Event
    June 3, 2014
    Report Date
    June 3, 2014
    Manufacturer
    COOK, INC.
    Product Code
    DYB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    AT THE END OF A LEFT DISTAL SUPERIOR FEMERAL ARTERY ANGIOPLASTY AND STENTING PROCEDURE, WITHOUT THE USE OF THE DILATOR, THE FLEXOR RAABE GUIDING SHEATH WAS BEING REMOVED WHEN IT GOT CAUGHT ON SOME CALCIUM AT THE ILIAC BIFURCATION AND TORE IN HALF LEAVING THE RIBBON WIRE COILS TRAILING OUT OF THE ACCESS SITE. AFTER APPROXIMATELY 3 HOURS THE PHYSICIAN WAS ABLE TO REMOVE THE TORN SHEATH FROM THE PATIENT. PER THE COOK REPRESENTATIVE, WHO WAS AT THE PROCEDURE, NO FRAGMENTS WERE LEFT IN THE PATIENT. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    376349 FLEXOR RAABE GUIDING SHEATH DYB INTRODUCER, CATHETER DYB COOK, INC. NA 4910070

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other