BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOSENSE WEBSTER SMART ABLATE

    MDR report key: 16353408 · Received February 9, 2023

    Report

    Report Number
    MW5114856
    Event Type
    Injury
    Date Received
    February 9, 2023
    Date of Event
    January 17, 2023
    Report Date
    February 7, 2023
    Manufacturer
    BIOSENSE WEBSTER, INC.
    Product Code
    LPB
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OR, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    ABLATION DEVICE FAILED TO ALARM LOW FLUID LEVEL, AIR VISUALIZED IN LINE BEHIND LIQUID. LINE DID SHUT DOWN WHEN AIR SENSED. PATIENT SUFFERED POST OPERATIVE STROKE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    957591 BIOSENSE WEBSTER SMART ABLATE CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER, INC. M490008

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Male Disability| H