BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERFORMER INTRODUCER

    MDR report key: 4200871 · Received September 18, 2014

    Report

    Report Number
    1820334-2014-00444
    Event Type
    Malfunction
    Date Received
    September 18, 2014
    Date of Event
    August 21, 2014
    Report Date
    August 22, 2014
    Manufacturer
    COOK, INC.
    Product Code
    DYB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    EVENT IS STILL UNDER INVESTIGATION.

    Description of Event or Problem · 1

    THE INTRODUCER SHEATH AND DILATOR WERE PLACED IN THE ARM OF THE CHILD. WHILE PULLING OUT THE DILATOR, AN INCISION WAS FOUND 2CM BEFORE THE TIP. AT THAT TIME, THE PHYSICIAN NOTED THAT THE ARTERY WALL WAS INJURED. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PT'S BODY. THE PT DID NOT REQUIRE ANY ADD'L PROCEDURES NOR EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    580329 PERFORMER INTRODUCER INTRODUCER, CATHETER DYB COOK, INC. NA 5058079

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK