BEUDAMED
    FDA Adverse Event Death Summary report: N

    RADIAL JAW

    MDR report key: 440225 · Received January 28, 2003

    Report

    Report Number
    6000123-2003-00002
    Event Type
    Death
    Date Received
    January 28, 2003
    Date of Event
    December 31, 2002
    Report Date
    January 2, 2003
    Manufacturer
    MICROVASIVE ENDOSCOPY, A DIVISION OF BOSTON SCIENTIFIC CORP.
    Product Code
    KNW
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE DEVICE WAS BEING USED DURING A BRONCHOSCOPY PROCEDURE FOR REMOVING TUMOR TISSUE IN THE UPPER RIGHT LOBE FOR THE PURPOSE OF PLACING A STENT. AFTER THE SECOND OF TWO SAMPLES WERE TAKEN TO REMOVE TISSUE, THE TUMOR BEGAN TO BLEED. EPINEPHRINE WAS IRRIGATED THROUGH THE SCOPE IN AN EFFORT TO STOP THE BLEEDING, BUT THE BLEEDING DID NOT STOP AND THE PT EXPIRED. THIS WAS THE ONLY PROCEDURE PERFORMED TO STOP THE BLEEDING. THE DOCTOR REPORTED THAT THE BLEEDING WAS CAUSED BY REMOVING A PIECE OF THE TUMOR WHICH WAS CONNECTED TO THE PULMONARY ARTERY. THE DOCTOR REPORTED THAT THE DEVICE WORKED WELL AND DID NOT MALFUNCTION. THE DEVICE WAS DESTROYED BY THE USER FACILITY AND, THEREFORE, WILL NOT BE RETURNED TO THIS MFR. SINCE THE DEVICE WAS NOT RETURNED, A FAILURE ANALYSIS COULD NOT BE PERFORMED. ALTHOUGH IT IS NOT BELIEVED THAT A DEVICE MALFUNCTION OCCURRED. A LOT DEVICE HISTORY SEARCH WAS NOT ABLE TO BE PERFORMED BECAUSE THE LOT NUMBER WAS NOT MADE AVAILABLE BY THE USER FACILITY. IT CANNOT BE DETERMINED IF THE PRODUCT MET SPECIFICATIONS BECAUSE THE PRODUCT WAS NOT RETURNED. THE CO IS UNABLE TO DETERMINE THE RELATIONSHIP BETWEEN THE DEVICE AND THE CAUSE OF THIS EVENT WITHOUT THE PRODUCT. HOWEVER, THE PHYSICIAN DID NOT FEEL THAT THIS DEVICE MALFUNCTIONED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RADIAL JAW BIOPSY FORCEPS KNW MICROVASIVE ENDOSCOPY, A DIVISION OF BOSTON SCIENTIFIC CORP. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Death