BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HERCULES 3 STAGE BALLOON ESOPHAGEAL

    MDR report key: 3212740 · Received July 2, 2013

    Report

    Report Number
    1037905-2013-00499
    Event Type
    Injury
    Date Received
    July 2, 2013
    Date of Event
    May 29, 2013
    Report Date
    June 4, 2013
    Manufacturer
    WILSON-COOK MEDICAL INC.
    Product Code
    KNQ
    PMA / PMN Number
    K061937
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION EVALUATION: A PRODUCT EVALUATION WAS NOT PERFORMED IN RESPONSE TO THIS REPORT BECAUSE THE PRODUCT SAID TO BE INVOLVED WAS NOT PROVIDED TO COOK FOR EVALUATION. 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 EVALUATION. A DEFINITIVE CAUSE FOR THE REPORTED OBSERVATION COULD NOT BE DETERMINED. 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: "THE ENTIRE BALLOON SHOULD BE EXTENDED BEYOND THE TIP OF THE ENDOSCOPE AND BE COMPLETELY VISUALIZED AND POSITIONED BEFORE INFLATION." THE INSTRUCTIONS FOR USE CONTAIN THE FOLLOWING WARNING: "THE RECOMMENDED 100% BALLOON INFLATION PRESSURE CAN BE FOUND ON THE SHRINK TUBE OF THE BALLOON DILATOR." OVER INFLATION CAN CAUSE DAMAGE TO THE BALLOON DILATOR, SUCH AS A RUPTURE OR SPLIT. 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. PRIOR TO DISTRIBUTION, ALL HERCULES 3 STAGE 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 MANUFACTURING REQUIREMENTS PRIOR TO SHIPMENT. CORRECTIVE ACTION: 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.

    Description of Event or Problem · 1

    DURING AN ENDOSCOPY PROCEDURE A COOK HERCULES 3 STAGE ESOPHAGEAL BALLOON WAS USED. THE BALLOON RUPTURED AND LEAKED WATER. THE BALLOON HAD BEEN HOLDING PRESSURE AT 12MM OR 6ATM FOR APPROXIMATELY 15 SECONDS PRIOR TO THE LEAK. THE PHYSICIAN PLACED BALLOON IN STOMACH AND ASPIRATED 20CC OF THE ORIGINAL 40CC IN BALLOON THEN THE BALLOON WAS REMOVED FROM THE PATIENT. THE PATIENT'S STOMACH SUCTIONED AND ENDOSCOPE REMOVED FROM THE PATIENT. OUR ATTEMPTS TO COLLECT ADDITIONAL INFORMATION REGARDING PATIENT OUTCOME WERE UNSUCCESSFUL. OTHER THAN WATER REMOVAL FROM THE PATIENT'S STOMACH, THE COMPLAINANT DID NOT SPECIFY IF THE PATIENT EXPERIENCED ANY ADVERSE EFFECTS OR REQUIRED ADDITIONAL MEDICAL PROCEDURES DUE TO THIS EVENT, THE INFORMATION ABLE TO BE COLLECTED DOES NOT REASONABLY SUGGEST THE PATIENT WAS ADVERSELY IMPACTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    300562 HERCULES 3 STAGE BALLOON ESOPHAGEAL KNQ, DILATOR, ESOPHAGEAL KNQ WILSON-COOK MEDICAL INC. W3238897

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention ENDOSCOPE (UNK MODEL NUMBER)| INFLATION DEVICE (UNK TYPE)