BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FUSION ZILVER BILIARY SELF-EXPANDING METAL STENT

    MDR report key: 1492710 · Received September 4, 2009

    Report

    Report Number
    1037905-2009-00151
    Event Type
    Malfunction
    Date Received
    September 4, 2009
    Date of Event
    August 6, 2009
    Report Date
    August 6, 2009
    Manufacturer
    COOK ENDOSCOPY
    Product Code
    FGE
    PMA / PMN Number
    K040930
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION: OUR LABORATORY EVALUATION OF THE PRODUCT SAID TO BE INVOLVED CONFIRMED THE REPORT. APPROXIMATELY 3MM OF THE DISTAL TIP HAS DETACHED FROM THE INTRODUCTION SYSTEM. THE DAMAGE AND COMPLETE SEPARATION OCCURRED AT THE INTRADUCTAL EXCHANGE (IDE) PORT, LOCATED 3MM FROM THE DISTAL END OF THE INTRODUCER TIP. THE APPEARANCE OF THE DAMAGED AREA OF THE TIP SUGGESTS THE INTRODUCTION SYSTEM WAS PULLED WITH FORCE. A PRODUCT DISCREPANCY OR ANOMALY THAT COULD HAVE CONTRIBUTED TO THIS OCCURRENCE WAS NOT OBSERVED. AFER A REVIEW OF THE DEVICE HISTORY RECORD FOR THE LOT NUMBER SAID TO BE INVOLVED, WE CAN REPORT NO DISCREPANCIES OR ANOMALIES WERE OBSERVED. WE WERE UNABLE TO CONDUCT A SAMPLE TEST FROM THIS LOT BECAUSE NONE OF THE PRODUCT FROM THIS LOT REMAINED IN FINISHED GOODS INVENTORY. 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: A DEFINITIVE CAUSE FOR THIS OBSERVATION COULD NOT BE DETERMINED BECAUSE THE ACTUAL USE CONDITIONS COULD NOT BE DUPLICATED IN THE LABORATORY SETTING. DUE TO A VARIETY OF CLINICAL CONDITIONS SUCH AS PATIENT ANATOMY, ENDOSCOPE POSITION OR PROGRESSION OF DISEASE STATE, WE COULD NOT REPRODUCE THE ACTUAL CONDITIONS OF PRODUCT USAGE DURING OUR LABORATORY ANALYSIS. THIS LIMITS OUR ABILITY TO CONCLUSIVELY DETERMINE A CAUSE. ADDITIONAL INFORMATION PROVIDED INDICATED RESISTANCE WAS ENCOUNTERED WHEN THE INTRODUCTION SYSTEM WAS ADVANCED INTO POSITION. RESISTANCE OF THIS NATURE CAN OCCUR IF THE STENT SYSTEM IS ADVANCED THROUGH A SEVERE STRICTURE. THE CONTRAINDICATIONS LISTED IN THE INSTRUCTIONS FOR USE INCLUDE INABILITY TO PASS THE WIRE GUIDE OR STENT THROUGH THE OBSTRUCTED AREA. THE INSTRUCTIONS FOR USE CAUTION THE USER NOT TO ATTEMPT STENT PLACEMENT IF THE WIRE GUIDE OR STENT CANNOT BE ADVANCED THROUGH THE OBSTRUCTED AREA. IF EXCESSIVE PRESSURE WAS APPLIED TO THE DEVICE, PERHAPS IN RESPONSE TO RESISTANCE DURING ADVANCEMENT, THIS COULD HAVE CAUSED DAMAGE TO THE TIP. FORCEFUL REMOVAL OF THE TIP FROM THE WIRE GUIDE UPON EXITING THE ENDOSCOPE AND PATIENT IS THE MOST LIKELY CAUSE FOR FULL SEPARATION OF THE TIP FROM THE INTRODUCTION SYSTEM. PRIOR TO DISTRIBUTION, ALL FUSION ZILVER BILIARY SELF-EXPANDING METAL STENTS ARE SUBJECTED TO A VISUAL INSPECTION TO ENSURE DEVICE INTEGRITY. A REVIEW OF THE DEVICE HISTORY RECORD CONFIRMED THAT THIS LOT MET MANUFACTURING REQUIREMENTS PRIOR TO SHIPMENT. CORRECTIVE ACTION: THE COMPLAINT RISK PRIORITY NUMBER (CRPN) FOR THIS TYPE OF OCCURRENCE HAS BEEN CALCULATED BASED ON THE RATE OF OCCURRENCE AND SEVERITY OF THE OUTCOME. BASED ON THIS ACTIVITY, NO CORRECTIVE ACTION IS WARRANTED AT THIS TIME. 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 FUSION ZILVER BILIARY SELF-EXPANDING METAL STENT. THE DEVICE WAS ADVANCED THROUGH THE ENDOSCOPE OVER A WIRE GUIDE. AS THE DEVICE WAS ADVANCED TOWARD THE PAPILLA, THE INTRODUCER TIP BEGAN TO TEAR AWAY FROM THE WIRE GUIDE. THE DEVICE WAS WITHDRAWN FROM THE ENDOSCOPE. AFTER REMOVAL FROM THE ENDOSCOPE AND PATIENT, APPROXIMATELY 2MM OF THE INTRODUCTION SYSTEM TIP DETACHED WHEN THE WIRE GUIDE WAS REMOVED. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. A FOREIGN OBJECT DID NOT HAVE TO BE RETRIEVED FROM THE PATIENT. NO ADDITIONAL MEDICAL PROCEDURES WERE REQUIRED DUE TO THIS OCCURRENCE. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OBSERVATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FUSION ZILVER BILIARY SELF-EXPANDING METAL STENT FGE, CATHETER, BILIARY, DIAGNOSTIC FGE COOK ENDOSCOPY W2674068

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK