BEUDAMED
    FDA Adverse Event Death Summary report: N

    INFLATION DEVICES

    MDR report key: 746655 · Received August 10, 2006

    Report

    Report Number
    6000143-2006-00001
    Event Type
    Death
    Date Received
    August 10, 2006
    Date of Event
    July 20, 2006
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    KNR
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE HAS BEEN RECEIVED BY THIS MANUFACTURER, BUT AN EVALUATION HAS NOT YET BEEN PERFORMED. THEREFORE, A FAILURE ANALYSIS IS NOT AVAILABLE AND WE ARE UNABLE TO DETERMINE IF THE DEVICE MET ITS SPECIFICATIONS. SHOULD FURTHER RELEVANT DETAILS BECOME AVAILABLE; A SUPPLEMENTAL MEDWATCH REPORT WILL BE FILED UNDER THE APPROPRIATE SEQUENCE NUMBER. WE ARE UNABLE TO DETERMINE THE RELATIONSHIP BETWEEN THIS DEVICE AND THE CAUSE FOR THIS EVENT AT THIS TIME. OUR DIRECTIONS FOR USE OUTLINE APPROPRIATE PLACEMENT, ACCESS AND MAINTENANCE PROCEDURES.

    Description of Event or Problem · 1

    THE COMPLAINANT REPORTED THAT THE INFLATION DEVICE WAS BEING INFLATED AND COULD NOT INFLATE TO THE PRESCRIBED PRESSUE. THE PROCEDURE WAS COMPLETED WITH A GOOD RESULT, BUT WITH A NOTICEABLE MUCOFAL TEAR. NO LEAK WAS NOTICED, CONFIRMED BY INJECTION OF CONTRAST AND SCREENING. THE PATIENT EXPIRED THE NEXT DAY ON THE WARD WITH AN OPHAGEAL PERFORATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INFLATION DEVICES ACHALASIA PNEUMATIC HAND PUMP KNR BOSTON SCIENTIFIC * UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Death