BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BOSTON SCI-MED

    MDR report key: 272515 · Received April 4, 2000

    Report

    Report Number
    272515
    Event Type
    Injury
    Date Received
    April 4, 2000
    Date of Event
    March 21, 2000
    Report Date
    March 30, 2000
    Manufacturer
    SCI-MED LIFE SYSTEMS, INC.
    Product Code
    MCX
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING PTCA/ROTOBLATOR PROCEDURE THE CIRCUMFLEX MARGINAL WIRE WAS SEVERED IN THE ARTERY BY THE BURR, CAUSING PERFORATION OF THE ARTERY. IABP WAS INSERTED, ATROPINE WAS ADMINISTERED FOR BRADYCARDIA AND THE PT UNDERWENT AN EMERGENT CABGX2 AND REMOVAL OF BROKEN WIRE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BOSTON SCI-MED ROTOBLATOR WIRE MCX SCI-MED LIFE SYSTEMS, INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Hospitalization| L| R