BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MANSFIELD

    MDR report key: 46012 · Received August 16, 1996

    Report

    Report Number
    46012
    Event Type
    Injury
    Date Received
    August 16, 1996
    Date of Event
    February 1, 1996
    Report Date
    April 10, 1996
    Manufacturer
    MANSFIELD BOSTON SCIENTIFIC CORP.
    Product Code
    DWZ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT UNDERWENT ENDOMYOCARDIAL BIOPSY. A DISPOSABLE BIOPTOME WAS USED TO OBTAIN MYOCARDIAL BIOPSY SPECIMENS. THE BIOPTOME WAS UNABLE TO RETRACTED. IT PERFORATED THE SUPERIOR VENA CAVA. ATRIAL PACING WIRE EXTRACTION SHEATHS WERE USED TO EXTRACT THE BIOPTOME. THE PT REMAINED HEMODYNAMICALLY STABLE BUT WAS KEPT OVERNIGHT FOR OBSERVATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MANSFIELD DISPOSABLE BIOPTOME DWZ MANSFIELD BOSTON SCIENTIFIC CORP. BYCEP #6251 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Hospitalization