BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEART TECHNO CORO WIRE

    MDR report key: 35298 · Received July 1, 1996

    Report

    Report Number
    35298
    Event Type
    Injury
    Date Received
    July 1, 1996
    Date of Event
    January 10, 1996
    Report Date
    January 24, 1996
    Manufacturer
    HEART TECHNOLOGY, INC.
    Product Code
    DQX
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DURING ROTATIONAL ATHERECTOMY PROCEDURE, CORONARY WIRE BROKE. SEGMENT LEFT IN LEFT CIRCUMFLEX ARTERY. PT SENT TO EMERGENCY OPEN HEART SURGERY. PT DISCHARGED TO HOME 1/18/96.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEART TECHNO CORO WIRE CORO WIRE DQX HEART TECHNOLOGY, INC. C WIRE

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Hospitalization| L| R