BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HERCULES 3 STAGE BALLOON ESOPHAGEAL

    MDR report key: 2904139 · Received January 3, 2013

    Report

    Report Number
    1037905-2013-00003
    Event Type
    Malfunction
    Date Received
    January 3, 2013
    Date of Event
    November 30, 2012
    Report Date
    December 7, 2012
    Manufacturer
    WILSON-COOK MEDICAL INC
    Product Code
    KNQ
    PMA / PMN Number
    K061937
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION EVAL: A PRODUCT EVAL WAS NOT PERFORMED IN RESPONSE TO THIS REPORT BECAUSE THE PRODUCT SAID TO BE INVOLVED WAS NOT PROVIDED TO COOK FOR EVAL. THE REPORT COULD NOT BE CONFIRMED. 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: WE COULD NOT CONDUCT A COMPLETE INVESTIGATION BECAUSE THE PRODUCT SAID TO BE INVOLVED WAS NOT RETURNED FOR EVAL. ACCORDING TO THE REPORT LUBRICATION AND NEGATIVE PRESSURE WAS NOT APPLIED TO THE BALLOON PRIOR TO ADVANCEMENT THROUGH THE ENDOSCOPE. THE INSTRUCTIONS FOR USE STATES: TO FACILITATE PASSAGE THROUGH THE ENDOSCOPE, APPLY NEGATIVE PRESSURE TO THE CATHETER. APPLY A LUBRICATING AGENT TO THE BALLOON TO FACILITATE PASSAGE THROUGH THE ENDOSCOPE ACCESSORY CHANNEL." A POSSIBLE CONTRIBUTING FACTOR TO BALLOON MATERIAL RUPTURE IS INADEQUATE LUBRICATION OF THE BALLOON WITH A WATER SOLUBLE LUBRICANT. THE INSTRUCTIONS FOR USE DIRECT THE USER TO APPLY A WATER SOLUBLE LUBRICANT TO THE BALLOON TO ALLOW EASIER PASSAGE THROUGH THE ACCESSORY CHANNEL. THIS ACTIVITY WILL AID IN ENDOSCOPIC ADVANCEMENT AND BALLOON PRESERVATION. THE INSTRUCTIONS FOR USE CAUTION THE USER THAT NEGATIVE PRESSURE IS MANDATORY TO MAINTAIN BALLOON DEFLATION. THE APPLICATION OF NEGATIVE PRESSURE WILL ASPIRATE ALL RESIDUAL AIR FROM THE BALLOON AND EASE ENDOSCOPIC ADVANCEMENT. NEGATIVE PRESSURE WILL ALSO AID IN BALLOON PRESERVATION AND OPTIMIZE BALLOON PERFORMANCE. A BALLOON RUPTURE 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 ALSO CONTAIN THE FOLLOWING PRECAUTION: "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." 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 RUPTURE OF THE BALLOON MATERIAL. OVER INFLATION CAN CAUSE DAMAGE TO THE BALLOON DILATOR, SUCH AS A RUPTURE OR SPLIT. THE INSTRUCTIONS FOR USE STATE: "DURING DILATION, DO NOT INFLATE BALLOON BEYOND THE MAXIMUM INDICATED INFLATION PRESSURE." PRIOR TO DISTRIBUTION, ALL HERCULES 3 ESOPHAGEAL BALLOONS ARE SUBJECTED TO A VISUAL INSPECTION AND FUNCTIONAL TESTING TO ENSURE DEVICE INTEGRITY. A REVIEW OF THE DEVICE HISTORY RECORD CONFIRMED THAT THE LOT SAID TO BE INVOLVED MET ALL MFR REQUIREMENTS PRIOR TO SHIPMENT. CORRECTIVE ACTION: CORRECTIVE ACTION IS NOT WARRANTED AT THIS TIME BASED ON THE QUALITY ENGINEERING RISK ASSESSMENT. QA WILL CONTINUE TO MONITOR FOR COMPLAINT TRENDS AND REASSESS THE RISK ASSESSMENT RESULTS AS POST MARKET FEEDBACK CONTINUES TO BECOME AVAILABLE.

    Description of Event or Problem · 1

    DURING THE PROCEDURE, TWO (2) COOK HERCULES 3 STAGE ESOPHAGEAL BALLOONS WERE USED IN THE ESOPHAGUS, ONE AFTER THE OTHER. NEITHER OF THE BALLOONS RECEIVED NEGATIVE PRESSURE AND LUBRICATION PRIOR TO ADVANCEMENT THROUGH THE ENDOSCOPE. ONCE INSIDE THE PT, THE BALLOONS WERE INFLATED WITH WATER. BOTH BALLOONS BROKE IN THAT THEY WERE LEAKING FROM THE ROOT OF THE BALLOON. A NEW DILATION BALLOON WAS USED TO FINISH THE PROCEDURE. SEE MDRS 1037905-2013-00002 AND 1037905-2013-00003. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PT'S BODY. THE PT DID NOT REQUIRE ANY ADD'L PROCEDURES DUE TO THIS OCCURRENCE. 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
    2446 HERCULES 3 STAGE BALLOON ESOPHAGEAL KNQ, DILATOR, ESOPHAGEAL KNQ WILSON-COOK MEDICAL INC W3156654

    Patients

    Seq Age Sex Outcome Treatment
    1 ALLIANCE II INFLATION DEVICE| ENDOSCOPE (UNK TYPE)