BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRANSEND EX 014/205 SOFT TIP

    MDR report key: 3060704 · Received April 16, 2013

    Report

    Report Number
    3008853977-2013-00071
    Event Type
    Malfunction
    Date Received
    April 16, 2013
    Date of Event
    March 27, 2013
    Report Date
    March 29, 2013
    Manufacturer
    BOSTON SCIENTIFIC COSTA RICA
    Product Code
    DQX
    PMA / PMN Number
    K931584
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS NOT AVAILABLE TO THE MANUFACTURE.

    Description of Event or Problem · 1

    DURING THE PROCEDURE THE DISTAL END OF THE GUIDEWIRE PARTIALLY BROKE OFF INSIDE THE PATIENT. THE DEVICE WAS COMPLETELY REMOVED FROM THE PATIENT. THE PROCEDURE WAS COMPLETED USING A DIFFERENT DEVICE. THERE WAS NO CLINICAL CONSEQUENCE TO THE PATIENT WHO WAS REPORTEDLY STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    162087 TRANSEND EX 014/205 SOFT TIP WIRE, GUIDE, CATHETER DQX BOSTON SCIENTIFIC COSTA RICA 14897023

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR ECHELON-14 MICROCATHETER(EV3)