BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAILMAN GUIDE WIRE

    MDR report key: 135061 · Received November 26, 1997

    Report

    Report Number
    6000059-1997-00008
    Event Type
    Injury
    Date Received
    November 26, 1997
    Date of Event
    October 24, 1997
    Report Date
    October 28, 1997
    Manufacturer
    SCIMED A DIVISION OF BOSTON SCIENTIFIC CORP.
    Product Code
    DQX
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    H.3 THE GUIDING WIRE WAS DISCARDED BY THE HOSP, SO NO RETURNED PRODUCT ANALYSIS WILL BE AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PTCA PROCEDURE, A DISSECTION OCCURRED WHILE ATTEMPTING TO PLACE THE WIRE. THE PT WENT TO SURGERY. PT STATUS IS LISTED AS "OK".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAILMAN GUIDE WIRE PTCA GUIDEWIRE DQX SCIMED A DIVISION OF BOSTON SCIENTIFIC CORP. .014" MAILMAN 300CM UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention