BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOSENSE CARTO 3 SYSTEM

    MDR report key: 5962894 · Received September 16, 2016

    Report

    Report Number
    MW5064848
    Event Type
    Injury
    Date Received
    September 16, 2016
    Date of Event
    August 23, 2016
    Report Date
    September 16, 2016
    Manufacturer
    BIOSENSE WEBSTER
    Product Code
    DRQ
    UDI-DI
    1237723342
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    DURING A CARDIAC ABLATION PROCEDURE, THE BIOSENSE CARTO 3 SYSTEM MAPPING SYSTEM MALFUNCTIONED CAUSING THE SURGICAL PROCEDURE TO BE ABORTED PRIOR TO ITS COMPLETION. DIAGNOSIS OR REASON FOR USE: DIRECTS THE SURGEON WHERE TO GO. IS THE PRODUCT COMPOUNDED: NO. IS THE PRODUCT OVER-THE-COUNTER: NO. EVENT ABATED AFTER USE STOPPED OR DOSE REDUCED: YES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    609992 BIOSENSE CARTO 3 SYSTEM BIOSENSE CARTO 3 SYSTEM DRQ BIOSENSE WEBSTER CARTO 3 SYSTEM 13457 1237723342

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization