BEUDAMED
    FDA Adverse Event Death Summary report: N

    ROTABLATOR

    MDR report key: 326647 · Received April 12, 2001

    Report

    Report Number
    326647
    Event Type
    Death
    Date Received
    April 12, 2001
    Date of Event
    April 3, 2001
    Report Date
    April 4, 2001
    Manufacturer
    HEART TECHNOLOGY INC
    Product Code
    DQX
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    KY, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    DURING A ROTATIONAL ATHERECTOMY, A ROTABLATOR FLOPPY GUIDE WIRE SPONTANEOUSLY FRACTURED; A PERFORATION OF RCA WALL RESULTED-APPROX 3-4 MM. PT DEVELOPED BRADYCARDIA AND HYPOTENSION, SUCCESSFULLY RESUSCITATED. DEVELOPED PEA (IDIOVENTRICULAR RHYTHM WITHOUT PACER) AND NOT ABLE TO BE RESUSCITATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    16739 ROTABLATOR FLOPPY GUIDE WIRE DQX HEART TECHNOLOGY INC * *

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Death