BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANGIODYNAMICS, INC.

    MDR report key: 5924406 · Received April 16, 2012

    Report

    Report Number
    5924406
    Event Type
    Injury
    Date Received
    April 16, 2012
    Date of Event
    April 9, 2012
    Report Date
    April 9, 2012
    Manufacturer
    ANGIODYNAMICS, INC.
    Product Code
    DQR
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    GA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    A (B)(4) MALE HAVING DECLOTTING OF LEFT AV GRAFT; DURING PROCEDURE MICROPUNCTURE GUIDEWIRE SAHEARED OFF DURING ACCESS TOWARDS ARTERIAL SIDE OF AV GRAFT. FOREIGN BODY (PIECE OF WIRE) FOUND UNDER X-RAY AND RETRIEVED WITH A SNARE WITHOUT DIFFICULTY. PATIENT SUFFERED NO HARM. PROCEDURE WAS COMPLETED. BROKEN GUIDEWIRE AND INTRODUCER AVAILABLE FOR EVALUATION. REF MFR #: 1319211-2012-00049.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANGIODYNAMICS, INC. 5F STANDARD MICRO-INTRODUCER KIT DQR ANGIODYNAMICS, INC. 565110

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention