BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLEXIMA ALL PURPOSE DRAINAGE CATHETER

    MDR report key: 1063636 · Received June 19, 2008

    Report

    Report Number
    2134265-2008-01734
    Event Type
    Malfunction
    Date Received
    June 19, 2008
    Report Date
    May 23, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    FFA
    PMA / PMN Number
    K944290
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER COMPLAINT COULD NOT BE CONFIRMED SINCE THE DEVICE WAS NOT RETURNED FOR PRODUCT ANALYSIS. BASED ON THE INFO IN THE EVENT DESCRIPTION, IT APPEARS THAT THE CATHETER DEVICE DISINTEGRATED AND TORE DUE TO THE EXPOSURE TO ALCOHOL. THE PRODUCT LABEL ON THE POUCH OF THE DEVICE INSTRUCTS THE USERS TO "SEE INSTRUCTIONS FOR USE" AND THE INSTRUCTIONS FOR USE, ALSO REFERRED TO AS DIRECTIONS FOR USE (DFU), FOR THE FLEXIMA APDL REG 6.3 F/25CM DEVICE HAS CLEAR INSTRUCTIONS TO THE USER, WARNING THEM NOT TO ALLOW ALCOHOL TO COME IN CONTACT WITH THE CATHETER SINCE EXPOSURE TO ALCOHOL MAY DAMAGE THE COATING/CATHETER. THE MOST PROBABLE ROOT CAUSE FOR THIS COMPLAINT IS USER/USE ERROR SINCE THE USER HAD NOT FOLLOWED THE INSTRUCTIONS IN THE DFU WHICH IS PACKAGED WITH DEVICE. A REVIEW OF THE DEVICE HISTORY RECORD COULD NOT BE PERFORMED SINCE THE LOT NUMBER WAS NOT PROVIDED IN THE COMPLAINT. A SHIP HISTORY WAS PERFORMED AND FOUND THAT ONE LOT (LOT NUMBER 11329861) WAS SOLD TO THE CUSTOMER IN THE PAST SIX MONTHS BEFORE THE BSC AWARE DATE. A DEVICE HISTORY RECORD REVIEW OF LOT NUMBER 11329861 WAS PERFORMED AND REVEALED NO RELATED ISSUES TO THIS COMPLAINT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER INSERTION OF THE ALL PURPOSE DRAINAGE CATHETER, FOR TREATMENT IN AN UNK LOCATION, THE CATHETER CONSISTENCY CHANGED. IT WAS STATED BY THE SALES REPRESENTATIVE "THE DRAINAGE CATHETER WAS PLACED INTO PT, FLUSHED WITH ABSOLUTE ALCOHOL AS AN AGENT. AFTER SOMETIME OF TASK, IT WAS DETECTED, THAT THERE IS A HOLE IN THE CATHETER AND IT APPEARED AS IF THE CATHETER WAS TEARING. THE CATHETER WAS THEN REMOVED FROM THE PT AND THE ACCESS SITE WAS BEING ALLOWED TO HEAL." ADDITIONAL INFO HAS BEEN REQUESTED, BUT IS NOT AVAILABLE AT THIS TIME. PT CONDITION IS LISTED AS O.K.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FLEXIMA ALL PURPOSE DRAINAGE CATHETER FFA TUBE, DRAINAGE, SUPRAPUBIC FFA BOSTON SCIENTIFIC CORPORATION M001271280

    Patients

    Seq Age Sex Outcome Treatment
    1