BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HERCULES 3 STAGE BALLOON ESOPHAGEAL

    MDR report key: 3063303 · Received April 11, 2013

    Report

    Report Number
    1037905-2013-00141
    Event Type
    Malfunction
    Date Received
    April 11, 2013
    Date of Event
    March 14, 2013
    Report Date
    March 15, 2013
    Manufacturer
    WILSON-COOK MEDICAL INC
    Product Code
    KNQ
    PMA / PMN Number
    K061937
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION EVALUATION: OUR EVALUATION OF THE RETURNED PRODUCT CONFIRMED THE REPORT. THERE WAS A 9CM SPLIT LENGTH WISE IN THE BALLOON MATERIAL. DUE TO THE SPLIT IN THE BALLOON MATERIAL THE DEVICE WAS NOT CAPABLE OF BEING INFLATED. NO PART OF THE BALLOON WAS MISSING. 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 CONDITIONS OF PRODUCT USAGE DURING OUR LABORATORY ANALYSIS. THIS LIMITS OUR ABILITY TO CONCLUSIVELY DETERMINE A CAUSE. 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 MATERIAL SPLIT 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 UNTIL THE DILATOR IS COMPLETELY VISUALIZED ENDOSCOPICALLY." THE INSTRUCTIONS FOR USE CONTAIN THE FOLLOWING INFORMATION: "THE BALLOON CAN BE INFLATED TO THREE DISTINCT DIAMETERS, AS INDICATED ON THE PACKAGE AND CATHETER TAG. DO NOT EXCEED THE MAXIMUM INDICATED INFLATION PRESSURE." 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: 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 ESOPHAGEAL DILATION, A COOK HERCULES 3 STAGE ESOPHAGEAL BALLOON WAS USED. THE BALLOON WAS ADVANCED INTO POSITION AND INFLATED WITH CONTRAST AND SALINE. THE PHYSICIAN INFLATED THE BALLOON WITH 2 ATM OF PRESSURE [BALLOON DIAMETER OF 18MM] AND HELD FOR 1 TO 2 MINUTES. THEN THE BALLOON WAS INFLATED TO 4 ATM OF PRESSURE [BALLOON DIAMETER OF 19MM] AND HELD FOR 1 TO 2 MINUTES. THEN THE BALLOON WAS INFLATED TO 6 ATM OF PRESSURE [BALLOON DIAMETER OF 20MM] AND HELD FOR 1 MINUTE. AT THIS TIME, THEY CONFIRMED BALLOON LEAKAGE. THE DEVICE WAS REMOVED AND THEY DETERMINED THE BALLOON HAD RUPTURED. SEE MDR 1037905-2013-00141. THE PHYSICIAN INSERTED ANOTHER COOK HERCULES 3 STAGE ESOPHAGEAL BALLOON FROM THE SAME LOT NUMBER. THE BALLOON WAS INFLATED IN THE SAME MANNER AS THE FIRST. A BALLOON RUPTURE OCCURRED WHEN 4.5-5 ATM OF PRESSURE HAD BEEN APPLIED [BALLOON DIAMETER BETWEEN 19MM AND 20MM]. SEE MDR 1037905-2013-00142. A BALLOON DILATION CATHETER FROM ANOTHER COMPANY WAS USED TO COMPLETE THE PROCEDURE. THE PHYSICIAN PROVIDED THE FOLLOWING COMMENT. THERE WAS NO METALLIC OBJECT(S) THAT COULD HAVE CAUSED RUPTURE WHILE THE BALLOONS WERE IN THE ESOPHAGUS. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENTS' BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    155485 HERCULES 3 STAGE BALLOON ESOPHAGEAL KNQ WILSON-COOK MEDICAL INC W3184653

    Patients

    Seq Age Sex Outcome Treatment
    1 ALLIANCE INFLATION DEVICE| OLYMPUS GIF 2.8MM CHANNEL ENDOSCOPE