BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOLUS DOUBLE PIGTAIL STENT WITH INTRODUCER

    MDR report key: 1191232 · Received September 24, 2008

    Report

    Report Number
    1037905-2008-00124
    Event Type
    Malfunction
    Date Received
    September 24, 2008
    Date of Event
    August 26, 2008
    Report Date
    August 26, 2008
    Manufacturer
    COOK ENDOSCOPY
    Product Code
    FGE
    PMA / PMN Number
    K851962/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION: THE USED STENT AND INTRODUCER WERE NOT RETURNED FOR EVALUATION. HOWEVER, ONE SEALED DEVICE FROM THE SAME LOT WAS RETURNED. OUR EVAL OF THE RETURNED SEALED DEVICE WAS UNABLE TO CONFIRM THE REPORT AS IT WAS DESCRIBED. A WIRE GUIDE FROM OUR SHELF STOCK WAS ADVANCED THROUGH AN ENDOSCOPE THAT IS IN A CURVED POSITION TO SIMULATE WORST-CASE SCENARIO. PER DIRECTION LISTED IN THE INSTRUCTIONS FOR USE, A WATER SOLUBLE LUBRICANT WAS APPLIED TO THE GUIDING CATHETER PRIOR TO LOADING THE STENT ONTO THE GUIDING CATHETER OF THE INTRODUCTION SYSTEM. THE STENT AND INTRODUCTION SYSTEM WERE ADVANCED OVER THE WIRE GUIDE AND THROUGH THE ACCESSORY CHANNEL OF THE ENDOSCOPE. THE PUSHING CATHETER OF THE INTRODUCTION SYSTEM WAS LEFT IN PLACE BEHIND THE STENT AND THE GUIDING CATHETER WAS EASILY REMOVED FROM THE STENT TO FACILITATE SMOOTH STENT DEPLOYMENT. THE INTRODUCTION SYSTEM AND WIRE GUIDE WERE REMOVED FROM THE STENT AND RESISTANCE DURING STENT DEPLOYMENT WAS NOT ENCOUNTERED. A DISCREPANCY OR ANOMALY THAT COULD HAVE CONTRIBUTED TO THE REPORTED OBSERVATION WAS NOT OBSERVED DURING OUR ANALYSIS OF THE RETURNED SEALED PRODUCT. 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 INFO, THE LIKELIHOOD OF THIS TYPE OF REPORT IS REMOTE. CONCLUSION: WE WERE UNABLE TO CONDUCT A FULL INVESTIGATION BECAUSE THE AFFECTED DEVICE WAS NOT RETURNED FOR EVAL. A DEFINITIVE CAUSE FOR THE REPORTED OBSERVATION WAS UNABLE TO BE DETERMINED BECAUSE THE USED DEVICE WAS NOT RETURNED AND THE SEALED PRODUCT FUNCTIONED AS INTENDED. INADEQUATE LUBRICATION OF THE GUIDING CATHETER WITH A WATER SOLUBLE LUBRICANT PRIOR TO ADVANCEMENT THROUGH THE ENDOSCOPE COULD HAVE CONTRIBUTED TO THE REPORTED GUIDING CATHETER REMOVAL DIFFICULTY. THE INSTRUCTIONS FOR USE INSTRUCT THE USER TO LUBRICATE THE GUIDING CATHETER WITH A WATER SOLUBLE LUBRICANT BEFORE ADVANCING THROUGH THE ACCESSORY CHANNEL OF THE ENDOSCOPE. THIS ACTIVITY WILL AID IN SMOOTH STENT DEPLOYMENT. PRIOR TO DISTRIBUTION, ALL SOLUS STENTS SETS ARE SUBJECTED TO A VISUAL, DIMENSIONAL AND FUNCTIONAL INSPECTION TO ENSURE DEVICE INTEGRITY. A REVIEW OF THE DEVICE HISTORY RECORD CONFIRMED THAT THIS LOT MET MFG REQUIREMENTS PRIOR TO SHIPMENT. CORRECTIVE ACTIONS: NO CORRECTIVE ACTION WARRANTED AT THIS TIME BECAUSE THIS REPORT WAS UNABLE TO BE VERIFIED. THIS 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 FURTHER ACTION IS WARRANTED AT THIS TIME. THE LIKELIHOOD OF THIS TYPE OF OCCURRENCE IS REMOTE. 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 SOLUS DOUBLE PIGTAIL STENT WITH INTRODUCER. THE STENT AND GUIDING CATHETER WERE ADVANCED THROUGH THE ENDOSCOPE INTO POSITION FOR STENT DEPLOYMENT. ONCE THE STENT WAS IN POSITION, THE GUIDING CATHETER OF THE INTRODUCTION SYSTEM COULD NOT BE REMOVED FROM THE STENT. THE INTRODUCTION SYSTEM AND STENT WERE REMOVED FROM THE ENDOSCOPE SIMULTANEOUSLY AND ANOTHER STENT WAS NOT PLACED. A FOREIGN OBJECT DID NOT HAVE TO BE RETRIEVED FROM THE PT. NO ADD'L 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 SOLUS DOUBLE PIGTAIL STENT WITH INTRODUCER FGE, CATHETER, BILIARY, DIAGNOSTIC FGE COOK ENDOSCOPY W2555527

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK