BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLEXOR ANSEL GUIDING SHEATH

    MDR report key: 3150098 · Received April 24, 2013

    Report

    Report Number
    1820334-2013-00186
    Event Type
    Malfunction
    Date Received
    April 24, 2013
    Date of Event
    March 21, 2013
    Report Date
    April 11, 2013
    Manufacturer
    COOK, INC.
    Product Code
    DYB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    A (B)(6) MALE UNDERWENT RENAL ARTERY CATHETER INSERTION ON (B)(6) 2013. DURING PROCEDURE, THE PHYSICIAN WAS PULLING AN ANSEL 1 GUIDING SHEATH OVER A WIRE AND THE SHEATH BROKE IN HALF. THE PHYSICIAN WAS ABLE TO PULL THE WIRE AND BROKEN PART OF THE SHEATH COMPLETELY OUT AND PRESSURE WAS HELD TO THE SITE. THERE WAS NO PT INJURY. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PT'S BODY. THE PT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    176638 FLEXOR ANSEL GUIDING SHEATH DYB INTRODUCER, CATHETER DYB COOK, INC. NA 2675160

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention