BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HERCULES 3 STAGE WIREGUIDED BALLOON ESOPHAGEAL-PYLORIC-COLONIC

    MDR report key: 4091994 · Received August 21, 2014

    Report

    Report Number
    1037905-2014-00329
    Event Type
    Injury
    Date Received
    August 21, 2014
    Date of Event
    July 24, 2014
    Report Date
    July 24, 2014
    Manufacturer
    WILSON-COOK MEDICAL INC.
    Product Code
    KNQ
    PMA / PMN Number
    K090183
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION EVALUATION: OUR EVALUATION OF THE RETURNED DEVICE CONFIRMED THE REPORT. THE DEVICE WAS RETURNED IN TWO PIECES. THE FIRST PIECE INCLUDED BOTH THE INNER AND OUTER CATHETER. THE SECOND PIECE INCLUDED THE BALLOON AND THE BALLOON TIP. THERE WAS A BEND IN THE CATHETER AT THE DISTAL END WHERE THE BALLOON WOULD BE ATTACHED. THE BALLOON APPEARED TO BE INTACT WITH NO OBVIOUS SPLITS OR TEARS. THERE WAS ADHESIVE PRESENT ON BOTH THE PROXIMAL AND DISTAL ENDS OF THE CATHETER WERE THE BALLOON IS ATTACHED TO THE CATHETER. A PRODUCT-SPECIFIC DISCREPANCY THAT COULD HAVE CAUSED OR CONTRIBUTED TO THIS OBSERVATION WAS NOT OBSERVED DURING OUR LABORATORY ANALYSIS. THE DEVICE HISTORY RECORD FOR THE LOT NUMBER SAID TO BE INVOLVED WAS REVIEWED. A DISCREPANCY OR ANOMALY WAS NOT OBSERVED WITH THE PRODUCT THAT WAS RELEASED FOR DISTRIBUTION. INVESTIGATION CONCLUSIONS: 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 CONDITION OF PRODUCT USAGE DURING OUR LABORATORY ANALYSIS. THIS LIMITS OUR ABILITY TO CONCLUSIVELY DETERMINE A CAUSE. ACCORDING TO THE REPORT LUBRICATION WAS NOT APPLIED TO THE BALLOON PRIOR TO ADVANCEMENT THROUGH THE ENDOSCOPE. A POSSIBLE CONTRIBUTING FACTOR TO RESISTANCE IN ADVANCEMENT AND REMOVAL FROM THE ACCESSORY CHANNEL IS INADEQUATE LUBRICATION OF THE BALLOON WITH A LUBRICATING AGENT. THE INSTRUCTIONS FOR USE DIRECT THE USER TO APPLY A LUBRICATING AGENT TO THE BALLOON TO FACILITATE PASSAGE THROUGH THE ENDOSCOPE ACCESSORY CHANNEL. THIS ACTIVITY WILL AID IN ENDOSCOPIC ADVANCEMENT BALLOON PRESERVATION. THE INSTRUCTIONS FOR USE DIRECT THE USER TO APPLY NEGATIVE PRESSURE TO THE CATHETER TO FACILITATE PASSAGE THROUGH THE ENDOSCOPE. THE APPLICATION OF NEGATIVE PRESSURE WILL ASPIRATE ALL RESIDUAL AIR FROM THE BALLOON AND EASE ENDOSCOPIC ADVANCEMENT AND REMOVAL. NEGATIVE PRESSURE WILL ALSO AID IN BALLOON PRESERVATION AND OPTIMIZE BALLOON PERFORMANCE. THE INSTRUCTIONS FOR USE CONTAIN THE FOLLOWING WARNING. "DO NOT ADVANCE THE BALLOON DILATOR IF RESISTANCE IS ENCOUNTERED. ASSESS THE CAUSE OF RESISTANCE TO DETERMINE IF DILATION SHOULD BE RE-ATTEMPTED." THE INSTRUCTIONS FOR USE DIRECT THE USER TO APPLY A VACUUM AND REMOVE ALL FLUID FROM THE BALLOON WHILE OBSERVING THE BALLOON ENDOSCOPICALLY. THEN, THE USER IS INSTRUCTED TO REMOVE THE DEFLATED BALLOON FROM THE ACCESSORY CHANNEL. THE APPLICATION OF A VACUUM WILL ASPIRATE ALL RESIDUAL FLUID FROM THE BALLOON AND EASE REMOVAL OF THE BALLOON FROM THE ENDOSCOPE. IF THESE INSTRUCTIONS ARE NOT FOLLOWED, THIS COULD HAVE CONTRIBUTED TO THE REPORTED OBSERVATION. THE INSTRUCTIONS FOR USE CONTAIN THE FOLLOWING PRECAUTION: "A COMPROMISED BALLOON MAY PROHIBIT REMOVAL FROM THE ENDOSCOPE ACCESSORY CHANNEL. REMOVAL OF THE ENDOSCOPE ALONG WITH THE COMPROMISED BALLOON MAY BE REQUIRED. A BALLOON MATERIAL FAILURE CAN OCCUR IF THE BALLOON IS INFLATED PRIOR TO ADVANCEMENT THROUGH THE ENDOSCOPE OR IF THE BALLOON IS INFLATED WHILE PARTIALLY OR FULLY INSIDE THE ACCESSORY CHANNEL OF THE ENDOSCOPE. THE INSTRUCTIONS FOR USE CONTAIN THE FOLLOWING PRECAUTION: "DO NOT PRE-INFLATE THE BALLOON." THE INSTRUCTIONS FOR USE STATE: "MAINTAIN BALLOON DEFLATION WITH NEGATIVE PRESSURE AND INTRODUCE INTO THE ACCESSORY CHANNEL OF THE ENDOSCOPE, ADVANCING IN SHORT INCREMENTS UNTIL THE DILATOR IS COMPLETELY VISUALIZED ENDOSCOPICALLY. MONITOR ENDOSCOPICALLY UNTIL THE BALLOON IS IN THE DESIRED POSITION WITHIN THE STRUCTURE." THE INSTRUCTIONS FOR USE CONTAIN THE FOLLOWING WARNING: DURING DILATION DO NOT INFLATE BALLOON BEYOND THE MAXIMUM INDICATED INFLATION PRESSURE, AS THIS COULD RESULT IN OVEREXTENSION OR BURSTING OF THE BALLOON. TO ACHIEVE INCREASINGLY LARGER BALLOON DIAMETERS, INCREASE PRESSURE AS INDICATED ON THE CATHETER TAG. ANOTHER POSSIBLE CONTRIBUTING FACTOR IS USING A COMPROMISED INFLATION DEVICE TO INFLATE THE BALLOON. IF THE PRESSURE READING OF THE INFLATION DEVICE IS INACCURATE, THIS COULD CONTRIBUTE TO OVER INFLATION, POSSIBLY RESULTING IN A FAILURE OF THE BALLOON MATERIAL. PRIOR TO DISTRIBUTION, ALL HERCULES 3 STAGE WIREGUIDED ESOPHAGEAL-PYLORIC-COLONIC BALLOONS RE SUBJECTED TO A LEAK TEST TO ENSURE DEVICE INTEGRITY. A REVIEW OF THE DEVICE HISTORY RECORD CONFIRMED THAT THE LOT SAID TO BE INVOLVED MET ALL MANUFACTURING REQUIREMENTS PRIOR TO SHIPMENT. CORRECTIVE ACTIONS: A REVIEW OF THE COMPLAINT HISTORY WAS CONDUCTED. THE LIKELIHOOD OF OCCURRENCE IS CONSIDERED RARE. CORRECTIVE ACTION IS NOT WARRANTED AT THIS TIME BASED ON THE QUALITY ENGINEERING RISK ASSESSMENT. QUALITY ASSURANCE WILL CONTINUE TO MONITOR FOR COMPLAINT TRENDS AND REASSESS THE RISK ASSESSMENT RESULTS AS POST MARKET FEEDBACK CONTINUES TO BECOME AVAILABLE. ADDITIONAL COMMENTS REGARDING THIS REPORT: BASED ON THE INFO PROVIDED, A COOK REPRESENTATIVE HAS BEEN DIRECTED TO CONTACT THE MEDICAL FACILITY INVOLVED IN AN EFFORT TO PROMOTE FURTHER EDUCATION AND UNDERSTANDING RELATED TO APPROPRIATE USAGE OF THIS PRODUCT.

    Description of Event or Problem · 1

    DURING THE PROCEDURE, A COOK HERCULES 3 STAGE WIREGUIDED BALLOON WAS USED. DURING DILATATION OF THE PAPILLA, THE BALLOON WAS DAMAGED AND WAS RETRIEVED WITH A SNARE. THE DETACHED SECTION WAS RETRIEVED WITH A SNARE. THE PT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURENCE. ACCORDING TO THE INITIAL REPORTER, THE PT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    504565 HERCULES 3 STAGE WIREGUIDED BALLOON ESOPHAGEAL-PYLORIC-COLONIC KNQ, DILATOR, ESOPHAGEAL KNQ WILSON-COOK MEDICAL INC. W3217790

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention COOK METII-35-260 WIRE GUIDE| COOK QBID-1 INFLATION DEVICE| OLYMPUS ERCP ENDOSCOPE (UNKNOWN MODEL NUMBER)