BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZILVER BILIARY SELF-EXPANDING STENT

    MDR report key: 1152846 · Received September 5, 2008

    Report

    Report Number
    1037905-2008-00122
    Event Type
    Injury
    Date Received
    September 5, 2008
    Date of Event
    August 13, 2008
    Report Date
    August 13, 2008
    Manufacturer
    COOK ENDOSCOPY
    Product Code
    FGE
    PMA / PMN Number
    K020788
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL: OUR EVAL OF THE RETURNED DEVICE CONFIRMED THE REPORT AS IT WAS DESCRIBED. A 29 CM SECTION OF THE INNER CATHETER HAS SEPARATED AT THE CONNECTION JOINT FROM THE REMAINDER OF THE INTRODUCTION SYSTEM. MAGNIFIED VISUAL INSPECTION OF THE SEPARATED AREA CONFIRMED THE INNER WALL OF THE TUBING WAS NOT ROUGHENED PROPERLY DURING MANUFACTURE. THEREFORE, THE INTRODUCTION SYSTEM DID NOT MEET THE APPLICABLE MANUFACTURING SPECIFICATION. ONE SEALED PRODUCT FROM THE AFFECTED LOT NUMBER WAS RETURNED FOR EVAL. MAGNIFIED VISUAL INSPECTION OF THE INNER WALL OF THE INNER CATHETER CONFIRMED THE TUBING WAS NOT ROUGHENED PROPERLY DURING MANUFACTURE. A REVIEW OF ALL ZILVER EXPANDABLE METAL BILIARY STENT SYSTEMS REMAINING ON THE FINISHED GOODS SHELF THAT WERE MADE BY THE SAME MANUFACTURING OPERATOR WAS CONDUCTED. TWO STENT SYSTEMS FROM EACH LOT MANUFACTURED BY THE SAME OPERATOR THAT REMAINED ON THE FINISHED GOODS SHELF WERE REMOVED FROM THE SHELF TO CONDUCT TESTING. THIS INVOLVED TEN LOTS AND A TOTAL OF TWENTY STENT SYSTEMS. ALL TWENTY STENT SYSTEMS WERE DISASSEMBLED AND WE CONFIRMED THE INNER CATHETERS HAD BEEN ROUGHENED APPROPRIATELY. ALL STENT SYSTEMS WERE MANUFACTURED ACCORDING TO SPECIFICATION. BASED ON THIS INFO, WE BELIEVE THIS ISSUE IS ISOLATED TO LOT NUMBER W2528796. AFTER A REVIEW OF THE DEVICE HISTORY RECORD FOR THIS LOT NUMBER, WE CAN REPORT THAT NO DISCREPANCIES OR ANOMALIES WERE OBSERVED. A REVIEW OF THE TWELVE MONTH COMPLAINT HISTORY FOR THIS PRODUCT FAMILY WAS CONDUCTED. BASED ON THIS REVIEW, THE LIKELIHOOD OF THIS TYPE OF REPORT IS RARE. CONCLUSION: THE AFFECTED DEVICE DID NOT MEET MANUFACTURING SPECIFICATIONS. THE STEP IN THE MANUFACTURING PROCESS THAT INVOLVES ROUGHENING THE WALL OF THE INNER CATHETER WAS INADVERTENTLY OMITTED DURING THE PRODUCTION OF THIS DEVICE. THIS IS THE CAUSE FOR INNER CATHETER SEPARATION AND DETACHMENT DURING USE. CORRECTIVE ACTION: A CORRECTIVE ACTION HAS BEEN INITIATED IN RESPONSE TO THIS OCCURRENCE. THIS PRODUCT WAS MANUFACTURED PRIOR TO THE INITIATION OF THIS CORRECTIVE ACTION. THE LIKELIHOOD OF THIS TYPE OF OCCURRENCE IS RARE. CUSTOMER QUALITY ASSURANCE WILL CONTINUE TO MONITOR FOR COMPLAINT TRENDS.

    Description of Event or Problem · 1

    DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP), THE PHYSICIAN USED A COOK ENDOSCOPY ZILVER BILIARY SELF-EXPANDING STENT. THE STENT DEPLOYED AS INTENDED AND THE INTRODUCTION SYSTEM WAS WITHDRAWN FROM THE ENDOSCOPE WITHOUT DIFFICULTY. UPON REMOVAL OF THE INTRODUCTION SYSTEM, A SECTION OF THE INTRODUCTION SYSTEM WAS NOTED TO BE MISSING. THE MISSING SECTION OF THE INTRODUCTION SYSTEM WAS LOCATED INSIDE THE DEPLOYED STENT EXTENDING FROM THE BILE DUCT INTO THE DUODENUM. THE DETACHED SECTION OF INTRODUCTION SYSTEM WAS REMOVED WITH FORCEPS. NO ADDITIONAL MEDICAL PROCEDURES WERE REQUIRED DUE TO THIS OCCURRENCE. THE PT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OBSERVATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZILVER BILIARY SELF-EXPANDING STENT FGE, BILIARY CATHETER AND ACCESSORIES FGE COOK ENDOSCOPY W2528796

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention