BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HERCULES 3 STAGE ESOPHAGEAL BALLOON

    MDR report key: 1881392 · Received October 7, 2010

    Report

    Report Number
    1037905-2010-00483
    Event Type
    Malfunction
    Date Received
    October 7, 2010
    Date of Event
    July 30, 2010
    Report Date
    August 2, 2010
    Manufacturer
    COOK ENDOSCOPY
    Product Code
    KNQ
    PMA / PMN Number
    K061937
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFO IN THIS REPORT WAS PROVIDED TO US BY OUR DISTRIBUTOR IN (B)(4) ON BEHALF OF A MEDICAL FACILITY IN (B)(6). (B)(4). THE INITIAL RPTR INFORMED THE COOK AREA REP OF THIS OCCURRENCE ON (B)(6) 2010. THE COOK AREA REP INFORMED COOK (B)(4) 2010. THE DESIGNATED COMPLAINT HANDLING UNIT (CUSTOMER QUALITY ASSURANCE) WAS NOT INFORMED OF THIS OCCURRENCE UNTIL (B)(4) 2010. THE APPROPRIATE PERSONNEL HAVE BEEN INFORMED OF THIS OCCURRENCE IN AN EFFORT TO PROMOTE TIMELY REPORTING OF THIS INFO. EVAL: OUR LABORATORY EVAL OF THE PRODUCT SAID TO BE INVOLVED CONFIRMED THE REPORT. A VISUAL EXAMINATION OF THE BALLOON MATERIAL CONFIRMED THE PRESENCE OF A LARGE SPLIT IN THE BALLOON MATERIAL. THE SPLIT IS POSITIONED LENGTHWISE ON THE BALLOON COMPONENT AND IS APPROX THE SAME LENGTH OF THE BALLOON. NO SECTION OF THE BALLOON MATERIAL IS MISSING FROM THE DEVICE. WHEN THE BALLOON IS INFLATED WITH WATER, WATER EXITS THE BALLOON MATERIAL AT THE LOCATION OF THE LARGE SPLIT. THE BALLOON WILL NOT HOLD PRESSURE AND CANNOT PERFORM DILATION IN THIS CONDITION. A PRODUCT SPECIFIC DISCREPANCY THAT COULD HAVE CAUSED OR CONTRIBUTED TO THIS OBSERVATION WAS NOT OBSERVED DURING OUR LABORATORY ANALYSIS. AFTER A REVIEW OF THE DEVICE HISTORY RECORD FOR THE LOT NUMBER SAID TO BE INVOLVED, WE CAN REPORT NO DISCREPANCIES OR ANOMALIES WERE OBSERVED. WE WERE UNABLE TO CONDUCT A SAMPLE TEST FROM THIS LOT BECAUSE NONE OF THE PRODUCT FROM THIS LOT REMAINED IN FINISHED GOODS INVENTORY. CONCLUSIONS: THE ADD'L INFO PROVIDED INDICATED THE BALLOON DID NOT RECEIVE NEGATIVE PRESSURE PRIOR TO ADVANCEMENT THROUGH THE ENDOSCOPE. THIS IS THE MOST LIKELY CAUSE FOR THE REPORTED OBSERVATION. 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 POSSIBLE CONTRIBUTING FACTOR TO BALLOON MATERIAL DAMAGE 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. 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 PREINFLATE THE BALLOON." THE INSTRUCTIONS FOR USE DIRECT THE USER TO ENSURE THE BALLOON IS COMPLETELY VISUALIZED AND POSITIONED BEFORE INFLATION. THE INSTRUCTIONS FOR USE CONTAIN THE FOLLOWING WARNING: "DURING DILATION, DO NOT INFLATE BALLOON BEYOND 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 BALLOON DILATORS ARE SUBJECTED TO A VISUAL EXAMINATION 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: NO CORRECTIVE ACTION WARRANTED AT THIS TIME BECAUSE THE INFO PROVIDED INDICATED THE PRODUCT WAS USED IN CONTRADICTION WITH THE INSTRUCTIONS FOR USE. THIS TYPE OF OCCURRENCE HAS BEEN BROUGHT TO THE ATTENTION OF THE APPROPRIATE INTERNAL PERSONNEL IN AN EFFORT TO HEIGHTEN AWARENESS. NO FURTHER ACTION TAKEN AT THIS TIME. CUSTOMER QUALITY ASSURANCE WILL CONTINUE TO MONITOR FOR COMPLAINT TRENDS.

    Description of Event or Problem · 1

    DURING ESOPHAGEAL DILATION PROCEDURE, THE PHYSICIAN USED A COOK ENDOSCOPY HERCULES 3 STAGE ESOPHAGEAL BALLOON. THE BALLOON WAS ADVANCED INTO POSITION AND INFLATED TO 6 ATM OF PRESSURE (FULL INFLATION). AT THIS TIME, THE BALLOON MATERIAL WAS NOTED TO HAVE A SPLIT (I.E. BALLOON RUPTURE). 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 RPTR, THE PT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HERCULES 3 STAGE ESOPHAGEAL BALLOON KNQ, ESOPHAGEAL DILATOR KNQ COOK ENDOSCOPY W2852954

    Patients

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