BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ROTABLATOR

    MDR report key: 61569 · Received January 10, 1997

    Report

    Report Number
    61569
    Event Type
    Injury
    Date Received
    January 10, 1997
    Date of Event
    December 18, 1996
    Report Date
    December 30, 1996
    Manufacturer
    HEART TECHNOLOGY, INC
    Product Code
    MCX
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    LA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PT IN CATH LAB FOR DEVICE PROCEDURE. UPON COMPLETION OF PROCEDURE, DEVICE REMOVED FROM VESSEL. REALIZED AT THIS TIME THAT SMALL WIRE TIP OF DEVICE REMAINED IN PT'S DISTAL PDA VESSEL. BRANCH OF VESSEL APPARENTLY TOO SMALL FOR RETRIEVAL OF WIRE TIP. (PT CURRENTLY STABLE.)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ROTABLATOR FLOPPY ROTAWIRE MCX HEART TECHNOLOGY, INC * 61382

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Life Threatening CARDIAC CATH| STENT PLACEMENT X2 RCA