BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOSENSE WEBSTER

    MDR report key: 1638194 · Received March 19, 2010

    Report

    Report Number
    MW5015224
    Event Type
    Injury
    Date Received
    March 19, 2010
    Date of Event
    March 1, 2010
    Report Date
    March 5, 2010
    Product Code
    LPB
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    SC, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    A 3.5 MM OPEN IRRIGATED TIP CATHETER WITH POWER OF 40 WATTS ASSOCIATED WITH STEAM POP CAUSING MYOCARDIAL PERFORATION. SUGGEST TO LIMIT POWER DELIVERY IN RIGHT/LEFT ATRIUM. NOT TO EXCEED 30 WATTS TO PREVENT PERFORATION / STEAM POP. PATIENT WENT TO SURGERY FOR REPAIR OF CORONARY SINUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIOSENSE WEBSTER IRRIGATED ABLATION CATHETER / THERMACOOL LPB

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Hospitalization| L