BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRANSEND EX 014/205 PLATINUM

    MDR report key: 3339563 · Received September 10, 2013

    Report

    Report Number
    3008853977-2013-00331
    Event Type
    Injury
    Date Received
    September 10, 2013
    Date of Event
    August 23, 2013
    Report Date
    September 4, 2013
    Manufacturer
    BOSTON SCIENTIFIC COSTA RICA
    Product Code
    DQX
    PMA / PMN Number
    K971254
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED TO MANUFACTURER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DISTAL TIP OF THE GUIDEWIRE DETACHED DURING THE PROCEDURE. THE BROKEN PIECE WAS REMOVED USING A SNARE WITHOUT ANY CLINICAL CONSEQUENCE TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    453780 TRANSEND EX 014/205 PLATINUM WIRE, GUIDE, CATHETER DQX BOSTON SCIENTIFIC COSTA RICA 15406412

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention