BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BOSTON SCIENTIFIC CORP.

    MDR report key: 7305659 · Received February 28, 2018

    Report

    Report Number
    MW5075592
    Event Type
    Injury
    Date Received
    February 28, 2018
    Date of Event
    December 17, 2017
    Report Date
    December 31, 2017
    Manufacturer
    BOSTON SCIENTIFIC CORP.
    Product Code
    GBO
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NJ, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PHYSICIAN WAS PERFORMING A RIGHT NEPHROSTOMY TUBE EXCHANGE ON A (B)(6)PREGNANT. AS THE CATHETER WAS BEING REMOVED, IT FRACTURED AND PART OF IT BROKE OFF IN THE SOFT TISSUE. THE PHYSICIAN WAS UNABLE TO RETRIEVE IT AFTER MULTIPLE ATTEMPTS. THE PT AND HER MOTHER WERE INFORMED OF THE INCIDENT. THE TUBE IS MOVING TOWARDS THE SKIN WHICH MAY MAKE IT EASIER TO RETRIEVE. THE PT WAS GIVEN THE OPTION AT THAT TIME TO RETURN THE OPERATING ROOM FOR RETRIEVAL BUT CHOSE TO WAIT. A NEW 10 FRENCH TUBE WAS REINSERTED AND SUTURED IN PLACE. THIS MAY BE A KNOWN COMPLICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    148596 BOSTON SCIENTIFIC CORP. NEPHROSTOMY TUBE GBO BOSTON SCIENTIFIC CORP.

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR Required Intervention