BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HERCULES 3 STAGE BALLOON ESOPHAGEAL

    MDR report key: 2172382 · Received June 22, 2011

    Report

    Report Number
    1037905-2011-00425
    Event Type
    Malfunction
    Date Received
    June 22, 2011
    Date of Event
    May 22, 2011
    Report Date
    May 23, 2011
    Manufacturer
    WILSON-COOK MEDICAL INC.
    Product Code
    KNQ
    PMA / PMN Number
    K061937
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL: DURING A VISUAL EXAMINATION OF THE PRODUCT SAID TO BE INVOLVED, WE CONFIRMED THE BALLOON IS IN THE DEFLATED POSITION AND EXHIBITS A SEVERE KINK IN THE BALLOON MATERIAL 8CM FROM THE DISTAL TIP. THE CATHETER TUBING DOES NOT EXHIBIT ANY STRETCHED OR DAMAGED AREAS. DURING A FUNCTIONAL EVAL, A COOK QUANTUM INFLATION DEVICE FILLED WITH WATER WAS USED TO INFLATE THE BALLOON. THE BALLOON INFLATED PROPERLY. A VISUAL EXAM OF THE INFLATED BALLOON DILATOR CONFIRMED THE PRESENCE OF A SMALL HOLE IN THE BALLOON MATERIAL. THE HOLE IS LOCATED NEAR THE PROXIMAL END OF THE DILATION BALLOON BUT IS NOT LOCATED IN THE BALLOON TO THE CATHETER JOINT. A SMALL AND STEADY STREAM OF WATER EXITS THE BALLOON AT THE LOCATION OF THE SMALL HOLE. THE BALLOON WILL NOT HOLD A STEADY PRESSURE AND DILATION PERFORMANCE IS LIKELY COMPROMISED IN THIS CONDITION DUE TO THE SLOW LOSS OF PRESSURE. THE INFLATION DEVICE WAS USED TO DEFLATE THE BALLOON, REMOVING THE WATER FROM THE BALLOON DILATOR. A MFG DISCREPANCY OR ANOMALY THAT COULD HAVE CONTRIBUTED TO THIS REPORT WAS NOT OBSERVED DURING OUR LAB EVAL. 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. A SAMPLE TEST FROM THIS LOT COULD NOT BE CONDUCTED BECAUSE NONE OF THE PRODUCT FROM THIS LOT REMAINED IN INVENTORY. CONCLUSION: A POSSIBLE CONTRIBUTING FACTOR TO A HOLE IN THE BALLOON MATERIAL 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 AND BALLOON PRESERVATION. ANOTHER POSSIBLE CONTRIBUTING FACTOR TO A HOLE IN THE BALLOON MATERIAL IS FAILURE TO APPLY NEGATIVE PRESSURE TO THE BALLOON DILATOR PRIOR TO ADVANCEMENT THROUGH THE ENDOSCOPE. 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. NEGATIVE PRESSURE WILL ALSO AID IN BALLOON PRESERVATION AND OPTIMIZE BALLOON PERFORMANCE. A HOLE IN THE BALLOON MATERIAL 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 DIRECT THE USER TO ENSURE THE BALLOON IS COMPLETELY VISUALIZED AND POSITIONED BEFORE INFLATION. PRIOR TO DISTRIBUTION, ALL HERCULES 3 STAGE ESOPHAGEAL BALLOON DILATORS ARE SUBJECTED TO A VISUAL EXAM TO ENSURE DEVICE INTEGRITY. A REVIEW OF THE DEVICE HISTORY RECORD CONFIRMED THAT THE LOT SAID TO BE INVOLVED MET ALL MFG REQUIREMENTS PRIOR TO SHIPMENT. CORRECTIVE ACTION: BASED ON THE QUALITY ENGINEERING RISK ASSESSMENT NO CORRECTIVE ACTION IS WARRANTED AT THIS TIME. A REVIEW OF THE COMPLAINT HISTORY WAS CONDUCTED. QUALITY ASSURANCE WILL CONTINUE TO MONITOR FOR COMPLAINT TRENDS.

    Description of Event or Problem · 1

    DURING AN UPPER ENDOSCOPY, THE PHYSICIAN USED A COOK HERCULES 3 STAGE ESOPHAGEAL BALLOON DILATOR. THE BALLOON WAS ADVANCED DOWN THE ENDOSCOPE, INTO THE ESOPHAGUS AND INFLATED. THE BALLOON BEGAN TO LEAK WHERE THE BALLOON MEETS THE CATHETER. IT WAS NOTED THE BALLOON HAD A PINHOLE. ANOTHER BALLOON WAS USED TO COMPLETE THE PROCEDURE. A FOREIGN OBJECT DID NOT HAVE TO BE RETRIEVED FROM THE PT. 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 HERCULES 3 STAGE BALLOON ESOPHAGEAL KNQ, ESOPHAGEAL DILATOR KNQ WILSON-COOK MEDICAL INC. W2660086

    Patients

    Seq Age Sex Outcome Treatment
    1 BOSTON SCIENTIFIC ALLIANCE INFLATION GUN| ENDOSCOPE (UNK MAKE AND MODEL)