BEUDAMED
    FDA Adverse Event Other Summary report: N

    BIOSENSE WEBSTER

    MDR report key: 805204 · Received January 12, 2007

    Report

    Report Number
    MW1041606
    Event Type
    Other
    Date Received
    January 12, 2007
    Date of Event
    December 7, 2006
    Report Date
    January 8, 2007
    Manufacturer
    BIOSENSE WEBSTER
    Product Code
    DYB
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    IN EP LAB DURING PROCEDURE, THE TIP OF THE PREFACE SHEATH (SIZE #8F) BECAME DISLODGED AND SLIPPED DOWN AROUND THE BIOSENSE WEBSTER LASSO CATHETER WHILE IN THE PT'S HEART. TREATING PHYSICIAN REMOVED THE SHEATH AND CATHETER TOGETHER AS A UNIT UNDER FLUOROSCOPY. NO KNOWN NEGATIVE PT OUTCOME. THIS WAS REPORTED TO THE MFR ON 12/8/06.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIOSENSE WEBSTER PREFACE GUIDING SHEATH-MULTIPURPOSE DYB BIOSENSE WEBSTER 301803M 13088353

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Other