BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEXIMA ALL PURPOSE DRAINAGE CATHETER

    MDR report key: 1180176 · Received September 29, 2008

    Report

    Report Number
    2134265-2008-02824
    Event Type
    Injury
    Date Received
    September 29, 2008
    Report Date
    May 6, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    FFA
    PMA / PMN Number
    K944290
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE BATCH HISTORY, HISTORICAL TRENDING, AND SIMILAR COMPLAINT TRENDING REVIEW FOR THE PRODUCT FAMILY WILL BE CONDUCTED. IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DIFFICULTY IS ENCOUNTERED IN REMOVING THE DRAINAGE CATHETER. THE OPERATOR IS CUTTING THE CATHETER TO RELEASE THE PIG-TAIL; HOWEVER, THE DRAIN IS NOT RELEASING AND THE SUTURE HAS REMAINED INSIDE THE PATIENT ON "ONE OR TWO" OCCASIONS. ADDITIONAL INFORMATION REGARDING THIS EVENT HAS BEEN REQUESTED, BUT HAS NOT BEEN RECEIVED.

    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

    Patients

    Seq Age Sex Outcome Treatment
    1 Other