BEUDAMED
    FDA Adverse Event Death Summary report: N

    FLEXIMA CATHETER

    MDR report key: 437124 · Received January 9, 2003

    Report

    Report Number
    6000037-2003-00001
    Event Type
    Death
    Date Received
    January 9, 2003
    Date of Event
    December 5, 2002
    Report Date
    December 10, 2002
    Manufacturer
    MEDI-TECH/A DIV OF BOSTON SCIENTIFIC CORP.
    Product Code
    GBX
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THIS CATHETER WAS SUCCESSFULLY PLACED FOR PERCUTANEOUS DRAINAGE OF A PANCREATIC ABSCESS. POST PLACEMENT A CT SCAN WAS PERFORMED AND IT WAS NOTED THAT THE TIP OF THE DRAINAGE CATHERTER HAD DETACHED AND REMAINED IN THE PATIENT. THE PATIENT SUBSEQUENTLY DIED. CO'S ATTEMPTS TO OBTAIN FURTHER DETAILS HAVE BEEN UNSUCCESSFUL. SHOULD FURTHER DETAILS BECOME AVAILABLE A SUPPLEMENTAL MEDWATCH REPORT WILL BE FILED UNDER THE APPROPRIATE SEQUENCE NUMBER. THIS DEVICE HAS NOT BEEN RECEIVED FOR EVALUATION. THEREFORE, A FAILURE ANALYSIS IS NOT AVAILABLE. AS A LOT NUMBER FOR THIS DEVICE WAS NOT PROVIDED, A DEVICE HISTORY SEARCH COULD NOT BE PERFORMED AND CO IS UNABLE TO DETERMINE IF THE DEVICE MET ITS SPECIFICATIONS. CO'S FOLLOW UP INDICATED THE PHYSICAN DID NOT ATTRIBUTE THE PATIENT'S DEATH TO THE EVENT OR THE PROCEDURE. THE CAUSE OF THE PATIENT'S DEATH IS BELIEVED TO BE SEPTICEMIA. HOWEVER, CO IS UNABLE TO DETERMINE THE RELATIONSHIP BETWEEN THE DEVICE AND THE CAUSE FOR THIS EVENT. CO'S DIRECTIONS FOR USE STATE: "THE CATHETER IS DESIGNED FOR PERCUTANEOUS DRAINAGE OF ABSCESS FLUID, BILIARY, NEPHROSTOMY, URINARY, PLEURAL EMPYEMAS, LUNG ABSCESSES, AND MEDIASTINAL COLLECTIONS."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FLEXIMA CATHETER MULITPURPOSE CATHETER GBX MEDI-TECH/A DIV OF BOSTON SCIENTIFIC CORP. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Death