BEUDAMED
    FDA Adverse Event Other Summary report: N

    EP TECH

    MDR report key: 379871 · Received March 6, 2002

    Report

    Report Number
    379871
    Event Type
    Other
    Date Received
    March 6, 2002
    Date of Event
    November 23, 2001
    Report Date
    March 1, 2002
    Manufacturer
    EP TECHNOLOGIES INC, FKA MANSFIELD BOSTON SCIENTIFIC
    Product Code
    KDQ
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PERICARDIAL SHEATH BEING REMOVED AND TIP OF CATHETER SHEARED OFF. PT TAKEN TO SURGERY FOR REMOVAL OF SAME. NO HARM TO PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EP TECH PERICARDIAL CENTESIS CATHETER KDQ EP TECHNOLOGIES INC, FKA MANSFIELD BOSTON SCIENTIFIC * *

    Patients

    Seq Age Sex Outcome Treatment
    1 89 YR Other