BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLEXIMA¿

    MDR report key: 2772388 · Received October 4, 2012

    Report

    Report Number
    2134265-2012-06146
    Event Type
    Malfunction
    Date Received
    October 4, 2012
    Date of Event
    July 17, 2012
    Report Date
    September 11, 2012
    Manufacturer
    BOSTON SCIENTIFIC - COSTA RICA (COYOL)
    Product Code
    FGE
    PMA / PMN Number
    K023870
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATED BY MANUFACTURER - AN UNKNOWN RESIDUE WAS NOTED THROUGH THE CATHETER HOLES AND OUTSIDE THE DEVICE. THE CATHETER PRESENTS SOME KINKS ALONG THE ENTIRE BODY. THE METAL CANNULA PRESENTED A KINK. ADDITIONALLY, IT WAS NOTICED THAT THE WHITE MATERIAL FROM THE PACKAGING CARD WAS ADHERING TO THE COATED SECTIONS OF THE CATHETER'S PIGTAIL. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE IS OPERATIONAL CONTEXT AS DEVICE PERFORMANCE WAS LIMITED DUE TO ANATOMICAL PROCEDURAL FACTORS. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING PREPARATION FOR A PERCUTANEOUS TRANSHEPATIC BILIARY DRAINAGE PROCEDURE, THE CATHETER BODY WAS DAMAGED. AS FLEXIMA CATHETER WAS OPENED AND PREPPED FOR USE IT WAS NOTED THAT THE CATHETER BODY WAS "IRREGULAR AND UNEVEN." THE DEVICE WAS NOT USED AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. HOWEVER; RETURNED DEVICE ANALYSIS REVEALED THAT A PORTION OF THE PACKAGING WAS STUCK TO THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FLEXIMA¿ CATHETER, BILIARY, DIAGNOSTIC FGE BOSTON SCIENTIFIC - COSTA RICA (COYOL) M001272600 0014856146

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR