BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BALLOON CATHETER

    MDR report key: 19071 · Received January 20, 1995

    Report

    Report Number
    MW1004823
    Event Type
    Malfunction
    Date Received
    January 20, 1995
    Date of Event
    December 26, 1994
    Report Date
    January 9, 1995
    Manufacturer
    MICROVASIVE ENDOSCOPY DIV. BOSTON SCIENTIFIC CORP.
    Product Code
    KCF
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NY, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    DURING PROCEDURE BALLOON BURST AND REMAINED IN THE PT. A SECOND CATHETER WAS USED AND THE BALLOON PIECE WAS OBSERVED IN THE DUODENUM, PASSED NATURALLY. NO PT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BALLOON CATHETER CATHETER, ESOPHAGEAL, BALLOON KCF MICROVASIVE ENDOSCOPY DIV. BOSTON SCIENTIFIC CORP.

    Patients

    Seq Age Sex Outcome Treatment
    1 *