BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRING WIRE GUIDE COMPON ENT

    MDR report key: 1143669 · Received August 29, 2008

    Report

    Report Number
    9680794-2008-00014
    Event Type
    Injury
    Date Received
    August 29, 2008
    Date of Event
    July 30, 2008
    Report Date
    August 29, 2008
    Manufacturer
    ARROW INTERNATIONAL INC
    Product Code
    DQX
    PMA / PMN Number
    K862056
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    SAMPLE WILL NOT BE RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE CUSTOMER THAT THIS EVENT INVOLVED AN INFANT. THE BABY WAS PRESENTED IN EMERGENCY WITH A "DOUBLE VOLVULUS" OF THE SMALL INTESTINE. THE CATHETER WAS INSERTED VIA LEFT SUBCLAVIAN VEIN IN 2008. A NEW CATHETER WAS INSERTED RIGHT SUBCLAVIAN BECAUSE THE FIRST CATHETER WAS NO LONGER FUNCTIONING PROPERLY. DUE TO DIFFICULTIES DURING INSERTION, A NEW GUIDEWIRE HAD TO BE USED. UNFORTUNATELY, THE GUIDEWIRE BROKE IN THE "INTRA IN THORACIC" TISSUES. AS A RESULT, A PORTION OF THE GUIDEWIRE REMAINED IN THE TISSUE. THE INFANT LATER EXPIRED DUE TO RENAL FAILURE AFTER 10 DAYS OF "AURIA". THE MEDICAL DEVICE IS NOT BEING DIRECTLY CONTRIBUTED TO THE EXPIRY OF THE INFANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPRING WIRE GUIDE COMPON ENT ADULT MULTI-LUMEN CATHETER PRODUCTS DQX ARROW INTERNATIONAL INC CF7121049

    Patients

    Seq Age Sex Outcome Treatment
    1 8 MO Death