BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZIMMON BILIARY STENT

    MDR report key: 3850381 · Received May 15, 2014

    Report

    Report Number
    3001845648-2014-00078
    Event Type
    Injury
    Date Received
    May 15, 2014
    Date of Event
    April 15, 2014
    Report Date
    April 16, 2014
    Manufacturer
    COOK IRELAND LTD
    Product Code
    FGE
    PMA / PMN Number
    K851962
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS PT REQUIRED REMOVAL OF A PIGTAIL STENT, WHICH WAS PLACED IN THE PT ON (B)(6) 2013. WHEN THE RETRIEVAL FORCEPS GRASPED THE STENT, ONLY THE END OF THE STENT CAME AWAY. THIS RESULTED IN TRYING TO RETRIEVE THE REST OF THE STENT FROM THE DUCT WITH A SNARE AND FORCEPS. THE INFO RECEIVED INDICATED THE STENT WAS SUCCESSFULLY RETRIEVED. THE DEVICE INVOLVED IN THIS COMPLAINT WAS NOT RETURNED TO COOK (B)(4) FOR EVAL. WITH THE INFO PROVIDED A DOCUMENT BASED INVESTIGATION WAS CARRIED OUT. AS PER THE PRODUCT IFU, "THIS DEVICE SHOULD NOT BE LEFT INDWELLING FOR MORE THAN THREE MONTHS OR AS DIRECTED BY A PHYSICIAN. PERIODIC EVAL IS RECOMMENDED." A POSSIBLE CAUSE OF DIFFICULTY IN RETRIEVING PART OF THE STENT MAY BE ATTRIBUTED TO THE STENT INDWELL TIME EXTENDING BEYOND THE RECOMMENDED TIME. THE INFO RECEIVED INDICATES THE STENT HAD BEEN INDWELLING FOR 5 MONTHS. IT IS UNKNOWN WHETHER PERIODIC EVAL WERE CARRIED OUT. THERE WERE NO ISSUES NOTED DURING STENT PLACEMENT, AND THE STENT POSITION WAS CONFIRMED AT THE END OF THE PROCEDURE. CLINICAL INPUT WAS RECEIVED IN RELATION TO THIS COMPLAINT STATED THAT 'SOMETIMES PHYSICIANS DECIDE TO LEAVE PLASTIC STENTS FOR LONGER TIME THAN THE THREE MONTHS SPECIFIED IN THE IFU. THIS IS A CLINICAL DECISION FROM EXPERT IN PT TREATMENT. STENTS ARE SOMETIMES LEFT IN FOR LONGER PERIOD, NORMALLY IF CLINICALLY PT IS DOING WELL...' ALL SECTIONS OF THE STENT WERE RETRIEVED FROM THE PT, AND THERE WERE NO FURTHER ADVERSE EFFECTS REPORTED AS A RESULT OF THIS COMPLAINT. THE COMPLAINT WAS CONFIRMED BASED ON CUSTOMER TESTIMONY. THERE WERE NO ZSO-7-4 (ZIMMON BILIARY STENT) DEVICES OF LOT # C921042 IN STOCK AT THE TIME OF THE COMPLAINT INVESTIGATION.. A REVIEW OF THE MANUFACTURING RECORDS FOR ZSO-7-4 (C921042) REVEALED NO DISCREPANCIES THAT COULD HAVE CONTRIBUTED TO THIS COMPLAINT. PRIOR TO DISTRIBUTION, ALL ZIMMON BILIARY STENT DEVICES ARE SUBJECTED TO VISUAL INSPECTION TO ENSURE DEVICE INTEGRITY. THE ZIMMON BILIARY STENT IS INTENDED FOR ONE TIME USE. THIS DEVICE IS USED TO DRAIN OBSTRUCTED BILIARY DUCTS. QUALITY ENGINEERING ASSESSED THE COMPLAINT AND THE OVERALL RISK HAS BEEN DETERMINED TO BE LOW. QUALITY ENGINEERING WILL CONTINUE TO MONITOR COMPLAINTS OF THIS NATURE FOR POTENTIAL EMERGING TRENDS.

    Description of Event or Problem · 1

    THIS PT REQUIRED REMOVAL OF A PIGTAIL STENT, WHICH WAS PLACED IN THE PT ON (B)(6) 2013. WHEN THE RETRIEVAL FORCEPS GRASPED THE STENT, ONLY THE END OF THE STENT CAME AWAY. THIS RESULTED IN TRYING TO RETRIEVE THE REST OF THE STENT FROM THE DUCT WITH A SNARE AND FORCEPS. THE INFO RECEIVED INDICATED THE STENT WAS SUCCESSFULLY RETRIEVED. NO FURTHER EFFECTS TO THE PT HAVE BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    291498 ZIMMON BILIARY STENT FGE CATHETER, BILIARY, DIAGNOSTIC FGE COOK IRELAND LTD C921042

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention