BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOSENSE WEBSTER

    MDR report key: 6185344 · Received December 13, 2016

    Report

    Report Number
    MW5066743
    Event Type
    Injury
    Date Received
    December 13, 2016
    Date of Event
    December 12, 2016
    Report Date
    December 13, 2016
    Manufacturer
    BIOSENSE WEBSTER
    Product Code
    MTD
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    PATIENT S/P AND FIBRILLATION ABLATION YESTERDAY. DURING PROCEDURE, PENTARAY CATHETER WAS CAUGHT AND BROKE OFF IN MECHANICAL MITRAL VALVE, LEAVING LEAFLET CLOSED. ONE FUNCTIONAL LEAFLET. PATIENT HAD EMERGENT HEART CATH IN THE CASE OF PATIENT REQUIRING EMERGENT SURGERY FOR VALVE. CORONARIES PATENT. PATIENT STABLE, DENIES PAIN, SHORTNESS OF BREATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    819713 BIOSENSE WEBSTER PENTARAY CATHETER MTD BIOSENSE WEBSTER 17564900L

    Patients

    Seq Age Sex Outcome Treatment
    1 3 MO Required Intervention