BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLEXIMA ALL PURPOSE DRAINAGE CATHETER

    MDR report key: 1203345 · Received October 15, 2008

    Report

    Report Number
    2134265-2008-03019
    Event Type
    Malfunction
    Date Received
    October 15, 2008
    Date of Event
    September 8, 2008
    Report Date
    September 15, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    FFA
    PMA / PMN Number
    K944290
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    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 DURING AN UNSPECIFIED PROCEDURE, WHEN THE PHYSICIAN TRIED TO REMOVE THE CANNULA, THE CATHETER TWISTED. HE MANAGED TO WITHDRAW THE DEVICE WITH A PIGTAIL CATHETER. HOWEVER, THE REPORTER STATED "THE PATIENT WAS PRICKED TWICE (INJURY AT THE POINT OF PUNCTURE)". ADDITIONAL INFORMATION HAS BEEN REQUESTED WITHOUT SUCCESS.

    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 M001271330 11792127

    Patients

    Seq Age Sex Outcome Treatment
    1