BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLEXIMA BILIARY CATHETER

    MDR report key: 1962552 · Received January 18, 2011

    Report

    Report Number
    2134265-2011-00071
    Event Type
    Malfunction
    Date Received
    January 18, 2011
    Report Date
    December 20, 2010
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    FGE
    PMA / PMN Number
    K023870
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MANUFACTURER: RECEIVED ONE FLEXIMA BILIARY REG RO 8F/35CM CATHETER IN A ZIPLOC BAG WITH RELATED COMPLAINT DEVICES. ONLY 1 ORIGINAL PRODUCT LABEL ON THE MYLAR SIDE OF THE POUCH WAS RECEIVED. THE TYVEK SIDE OF THE POUCH WAS NOT RETURNED NOR ANY OF THE COMPONENTS. NO RESIDUE WAS PRESENT ON THE DEVICE INDICATING IT HAD NOT BEEN USED. FROM A VISUAL EVALUATION, IT WAS FOUND THAT WHITE MATERIAL WAS STUCK TO COATED SECTION OF THE CATHETER INCLUDING THE PIGTAIL. ALSO, THE PIGTAIL OF THE CATHETER WAS KINKED/FLATTENED AT THE DISTAL SUTURE HOLE. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE WAS UNABLE TO BE DETERMINED. (B)(4)

    Description of Event or Problem · 1

    SAME CASE AS MFR REPORT #: 2134265-2011-00070, 2134265-2011-00072, 2134265-2011-00073. REPORTABLE BASED ON ANALYSIS COMPLETED (B)(4) 2010. IT WAS REPORTED THAT DURING THE PREPARATION FOR A BILIARY DRAINAGE PROCEDURE, THE DEVICE WAS STUCK IN THE PACKAGING. WHILE UNPACKING THE FLEXIMA BILIARY DRAINAGE CATHETER DURING THE PREPARATION FOR THE PROCEDURE, IT WAS NOTED THAT THE PIGTAIL PORTION OF THE DEVICE WAS STUCK TO THE PACKAGING. THREE SUBSEQUENT DEVICES WITH THE SAME LOT HAD WERE REPORTED WITH THE SAME ISSUE. NO ATTEMPT WAS MADE TO USE ANY OF THE DEVICES. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. ANALYSIS OF THE RETURNED DEVICE REVEALED FOREIGN MATERIAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FLEXIMA BILIARY CATHETER CATHETER, BILIARY, DIAGNOSTIC FGE BOSTON SCIENTIFIC - SPENCER M001272600 13260332

    Patients

    Seq Age Sex Outcome Treatment
    1