BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CHOICE PT EXCHANGE

    MDR report key: 51253 · Received November 22, 1996

    Report

    Report Number
    51253
    Event Type
    Injury
    Date Received
    November 22, 1996
    Date of Event
    October 19, 1996
    Report Date
    October 25, 1996
    Manufacturer
    SCIMED LIC.
    Product Code
    DQX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    GUIDE WIRE WITH ICE HYDROPHILIC COATING PERFORATED DISTAL BRANCH OF RCA, RESULTING IN PERICARDIAL EFFUSION, RESULTING IN NEED FOR PERICARDIAL TAP AND SURGICAL INTERVENTION AT ANOTHER HOSP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CHOICE PT EXCHANGE EXTRA SUPPORT GUIDE WIRE WITH ICE HYDROPHILIC CO DQX SCIMED LIC. UNK E05462

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Hospitalization| L| R LOPRESSOR 25 BID, ASPIRIN 1 QD