BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    E-LUMINEXX BILIARY STENT

    MDR report key: 5230604 · Received November 17, 2015

    Report

    Report Number
    9681442-2015-00220
    Event Type
    Malfunction
    Date Received
    November 17, 2015
    Date of Event
    October 22, 2015
    Report Date
    October 23, 2015
    Manufacturer
    ANGIOMED GMBH & CO. MEDIZINTECHNIK KG
    Product Code
    FGE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE LOT HISTORY RECORDS HAVE BEEN REVIEWED WITH SPECIAL ATTENTION TO THE MANUFACTURING AND INSPECTION OF THIS PRODUCT AND THE PRODUCT WAS FOUND TO HAVE MET ALL SPECIFICATIONS PRIOR TO SHIPMENT. THERE IS NO INDICATION FOR A MANUFACTURING-RELATED FAILURE. THE EVALUATION OF THE RETURNED DEVICE CONFIRMED THE REPORTED IMPOSSIBILITY TO ADVANCE THE DELIVERY SYSTEM OVER THE RETURNED 0.038 INCH GUIDE WIRE. THE BROKEN INNER CATHETER WAS FOUND STUCK ON THE RETURNED 0.038 INCH GUIDE WIRE. POTENTIAL FACTORS THAT COULD HAVE LED OR CONTRIBUTED TO THE REPORTED EVENT HAVE BEEN CONSIDERED. PREVIOUS INVESTIGATIONS OF SIMILAR COMPLAINTS HAVE BEEN REVIEWED. IN THIS CASE, A GUIDE WIRE WITH A LARGER DIAMETER (0.038 INCH) THAN RECOMMENDED IN THE IFU AND THE PRODUCT LABELING WAS USED DURING THE PROCEDURE LEADING TO THE REPORTED FAILURE TO ADVANCE THE SYSTEM OVER THE GUIDE WIRE AND THE SUBSEQUENT INNER CATHETER BREAKAGE. THE IFU STATES: "THE CATHETER TIP IS TAPERED TO ACCOMMODATE A 0.035" (0.89 MM) GUIDEWIRE." ALSO THE PRODUCT LABELING ON THE DEVICE PACKAGING RECOMMENDS THE USE OF A 0.035 INCH GUIDE WIRE.

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORDS ARE BEING REVIEWED. THE EVENT IS CURRENTLY UNDER INVESTIGATION. ALTHOUGH THIS PRODUCT IS NOT SOLD IN THE U.S., THIS EVENT IS BEING REPORTED UNDER REGULATION 21CFR PART 803 AS IT INVOLVES A SIMILAR DEVICE TO A PMA APPROVED DEVICE SOLD IN THE U.S. UNDER # K063532. THE INFORMATION PROVIDED BY BARD REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT WAS UNABLE TO PROVIDE FURTHER PATIENT DETAILS. THERE WAS NO PATIENT INVOLVEMENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT IT WAS DIFFICULT TO ADVANCE THE DELIVERY SYSTEM OVER THE GUIDE WIRE PRIOR TO USE IN THE PATIENT. THE DEVICE WAS REMOVED WITHOUT ISSUE. ANOTHER DEVICE OF THE SAME BRAND AND STIFF GUIDE WIRE WERE USED TO COMPLETE THE PROCEDURE SUCCESSFULLY. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    760985 E-LUMINEXX BILIARY STENT BILIARY STENT FGE ANGIOMED GMBH & CO. MEDIZINTECHNIK KG ANYG0271

    Patients

    Seq Age Sex Outcome Treatment
    1