BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FGE CATHETER, BILIARY, DIAGNOSTIC

    MDR report key: 5595353 · Received April 21, 2016

    Report

    Report Number
    3001845648-2016-00106
    Event Type
    Injury
    Date Received
    April 21, 2016
    Report Date
    March 21, 2016
    Manufacturer
    COOK IRELAND LTD
    Product Code
    FGE
    PMA / PMN Number
    K060624
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HK
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE FS-MARS-10-X OF UNKNOWN RPN OR LOT NUMBER WAS NOT RETURNED TO CIRL FOR EVALUATION. LIMITED INFORMATION WAS PROVIDED BY THE CUSTOMER AND IF ADDITIONAL INFORMATION BECOMES AVAILABLE THE COMPLAINT FILE WILL BE UPDATED TO REFLECT THIS. THE CUSTOMER¿S COMPLAINT WAS CONFIRMED ON CUSTOMER TESTIMONY. IT MAY BE NOTED THAT ACCORDING TO THE INSTRUCTIONS FOR USE, THE USER IS INSTRUCTED TO:¿ IF THE PACKAGE IS OPENED OR DAMAGED WHEN RECEIVED, DO NOT USE. VISUALLY INSPECT WITH PARTICULAR ATTENTION TO KINKS, BENDS AND BREAKS. IF AN ABNORMALITY IS DETECTED THAT WOULD PROHIBIT PROPER WORKING CONDITION, DO NOT USE. PLEASE NOTIFY (B)(4) FOR RETURN AUTHORIZATION ¿ ALSO PER IFU ¿STENT SHOULD BE CHECKED PERIODICALLY FOR SIGNS OF BILIARY OBSTRUCTION. THIS STENT SHOULD NOT BE LEFT INDWELLING FOR MORE THAN THREE MONTHS OR AS DIRECTED BY PHYSICIAN. THE WIRE GUIDE DIAMETER AND THE INNER LUMEN OF THE WIRE-GUIDED DEVICE MUST BE COMPATIBLE.¿ AS PER CIRL FUNCTIONAL CHECKS THERE IS 100% INSPECTION ON STENTS FOR KINKS AND A CHECK THAT THE APPROPRIATE SIZE WIRE GUIDE MOVES SMOOTHLY AND FREELY WHEN INSERTED INTO BOTH ENDS OF THE STENT. THERE IS ALSO A VISUAL INSPECTION OF THE PRODUCT AND PACKAGING AT PACKAGING, PACKAGING QC, AND POST STERILE QC. A REVIEW OF THE MANUFACTURING RECORDS FOR THE BILIARY STENT DEVICE OF UNKNOWN LOT NUMBER COULD NOT BE COMPLETED. PRIOR TO DISTRIBUTION, ALL FS-MAR ¿X DEVICES ARE SUBJECTED TO 100% INSPECTION TO ENSURE DEVICE INTEGRITY. THESE INSPECTIONS AND FUNCTIONAL CHECKS ARE OUTLINED IN INTERNAL PROCEDURES IN PLACE AT CIRL. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID REQUIRE ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. THERE WAS MEDICAL INTERVENTION (EXCHANGED STENTS) CARRIED OUT AS A RESULT OF THE OCCURRENCE OF PREMATURE STENT OCCLUSION WITHIN THE LESION WHERE A FS-MAR-10-X STENT WAS INDWELLING. IT WAS REPORTED THAT THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR POTENTIAL EMERGING TRENDS.

    Description of Event or Problem · 1

    AS PER THE RESULTS PARAGRAPH ON THE FIRST PAGE ¿FIVE OF 7 SUBJECTS (71%) IN GROUP B HAD STENT OCCLUSION WITHIN 8 DAYS.¿ SEE THIS ISSUE ALSO REFERENCED ON (B)(4) ¿THE ENROLMENT PROCESS WAS INTERRUPTED BEFORE THE PROJECTED NUMBER FOR EACH GROUP WAS REACHED DUE TO SAFETY CONCERNS. THERE WERE PREMATURE NUMBERS OF STENT OCCLUSION OR MALFUNCTION WITHIN THE FIRST WEEK OF STENT INSERTION¿ SEE ALSO ¿CONTRARY TO WHAT WAS EXPECTED OUR DATA SHOWED A TREND TOWARD PREMATURE STENT OCCLUSION IN THE ARBS GROUP MORE SO THAN THE GROUP WITH THE OTS PLASTIC STENT.¿ SEE ALSO (B)(4) ¿¿OUR DATA SUGGESTED A GREATER TENDENCY FOR THE ARBS TO BECOME OCCLUDED PREMATURELY. THE EXCEPTIONALLY SHORT MEDIAN PATENCY PERIOD OF 8 DAYS IN THIS GROUP INDICATED EARLY STENT FAILURE RATHER THAN THE USUAL STENT OCCLUSION RESULTING FROM SLUDGE FORMATION.¿

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    251464 FGE CATHETER, BILIARY, DIAGNOSTIC FGE COOK IRELAND LTD

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention