BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROTOBLATOR GUIDE WIRE

    MDR report key: 8156 · Received May 20, 1994

    Report

    Report Number
    8156
    Event Type
    Malfunction
    Date Received
    May 20, 1994
    Date of Event
    March 29, 1994
    Report Date
    March 30, 1994
    Manufacturer
    HEART TECHNOLOGY, INC.
    Product Code
    MCX
    Product Problem
    Yes
    Report Source
    User Facility report

    Narratives

    Description of Event or Problem · 1

    IT IS THOUGHT THAT AS THE GUIDE WIRE WAS BEING ADVANCED, AN APPROX ONE CM IN LENGTH PIECE OF DISTAL TIP OF GUIDE WIRE SEPARATED AND FLOWED DOWNSTREAM. THE TIP LODGED IN THE LEFT CIRCUMFLEX CORONARY ARTERY. THE PT HAS SUFFERED NO ADVERSE PROBLEMS SINCE THE INCIDENT.DEVICE LABELED FOR SINGLE USE. PATIENT MEDICAL STATUS PRIOR TO EVENT: FAIR CONDITION. THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE. NO DATA - REGARDING DATE LAST SERVICED. SERVICE PROVIDED BY: INVALID DATA. INVALID DATA - SERVICE RECORDS AVAILABILITY.NO IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED. DEVICE USED AS LABELED/INTENDED.INVALID DATA - REGARDING EVALUATION BY USER AFTER EVENT. METHOD OF EVALUATION: NONE OR UNKNOWN. RESULTS OF EVALUATION: OTHER, OTHER, GUIDEWIRE. CONCLUSION: DEVICE FAILURE OCCURRED AND WAS RELATED TO EVENT. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: INVALID DATA. CORRECTIVE ACTIONS: DEVICE PERMANENTLY REMOVED FROM SERVICE. INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ROTOBLATOR GUIDE WIRE GUIDE WIRE MCX HEART TECHNOLOGY, INC. TYPE C SOFT 27731

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Other