BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUANTUM TTC ESOPHAGEAL BALLOON DILATOR

    MDR report key: 1853759 · Received September 3, 2010

    Report

    Report Number
    1037905-2010-00437
    Event Type
    Malfunction
    Date Received
    September 3, 2010
    Date of Event
    April 29, 2010
    Report Date
    August 4, 2010
    Manufacturer
    COOK ENDOSCOPY
    Product Code
    KNQ
    PMA / PMN Number
    K935094
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION: OUR LABORATORY EVALUATION OF THE PRODUCT SAID TO BE INVOLVED CONFIRMED THE REPORT. A VISUAL EXAMINATION OF THE BALLOON MATERIAL CONFIRMED THE PRESENCE OF A SMALL HOLE IN THE BALLOON MATERIAL NEAR THE DISTAL END OF THE DILATION BALLOON. NO SECTION OF THE BALLOON MATERIAL IS MISSING FROM THE DEVICE. WHEN THE BALLOON IS INFLATED WITH WATER, A SMALL AND STEADY STREAM OF WATER EXITS THE BALLOON MATERIAL 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. 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: 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. THE REPORTER WAS UNABLE TO SPECIFY IF THE BALLOON WAS LUBRICATED PRIOR TO ADVANCEMENT THROUGH THE ACCESSORY CHANNEL OF THE ENDOSCOPE. 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. THE REPORTER WAS UNABLE TO SPECIFY IF NEGATIVE PRESSURE WAS APPLIED TO THE BALLOON DEVICE PRIOR TO ADVANCEMENT THROUGH THE ACCESSORY CHANNEL OF THE ENDOSCOPE. 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 SMALL 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 ALSO CONTAIN THE FOLLOWING PRECAUTION: "THE ENTIRE QUANTUM BALLOON SHOULD BE EXTENDED BEYOND THE TIP OF THE ENDOSCOPE AND BE COMPLETELY VISUALIZED AND POSITIONED BEFORE INFLATION." THE INSTRUCTIONS FOR USE INSTRUCT THE USER THAT THE RECOMMENDED 100% BALLOON INFLATION PRESSURE CAN BE FOUND ON THE CATHETER TAG OF THE QUANTUM BALLOON DILATOR. OVER INFLATION CAN CAUSE A SPLIT IN THE BALLOON MATERIAL. 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 SPLIT IN THE BALLOON MATERIAL. PRIOR TO DISTRIBUTION, ALL LOTS ARE SUBJECTED TO A TEST THAT MEASURES THE OUTER DIAMETER AND PRESSURE. A REVIEW OF THE DEVICE HISTORY RECORD CONFIRMED THAT THE LOT SAID TO BE INVOLVED MET ALL MANUFACTURING REQUIREMENTS PRIOR TO SHIPMENT. CORRECTIVE ACTION: THE APPROPRIATE PERSONNEL HAVE BEEN INFORMED OF THIS TYPE OF REPORT IN AN EFFORT TO HEIGHTEN AWARENESS. THIS WAS BROUGHT TO THE ATTENTION OF THE QUALITY REVIEW BOARD (QRB). CUSTOMER QUALITY ASSURANCE WILL CONTINUE TO MONITOR FOR COMPLAINT TRENDS.

    Description of Event or Problem · 1

    ON 07/30/2010, THE FOLLOWING INFORMATION WAS PROVIDED TO COOK ENDOSCOPY: DURING AN ESOPHAGOGASTRODUODENOSCOPY, THE BALLOON LEAKED NEAR THE HANDLE AS THEY INFLATED THE QUANTUM TTC ESOPHAGEAL BALLOON DILATOR. THIS PREVENTED BALLOON INFLATION. WHEN THEY USED ANOTHER QUANTUM TTC ESOPHAGEAL BALLOON DILATOR, THEY WERE ABLE TO COMPLETE THE PROCEDURE. AT THIS TIME, THE INFORMATION DID NOT REASONABLY SUGGEST THAT A REPORTABLE EVENT HAD OCCURRED. ON 08/04/2010, THE DEVICE WAS RETURNED FOR EVALUATION. UPON EVALUATION, WE CONFIRMED THE BALLOON MATERIAL LEAKED FROM A SMALL HOLE IN THE BALLOON MATERIAL. BECAUSE BALLOON LEAKAGE FROM A HOLE IN THE BALLOON MATERIAL HAS BEEN ESTABLISHED AS A REPORTABLE EVENT, WE ARE SUBMITTING THIS REPORT. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT'S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL MEDICAL PROCEDURES DUE TO THIS OCCURRENCE. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 QUANTUM TTC ESOPHAGEAL BALLOON DILATOR KNQ, DILATOR, ESOPHAGEAL KNQ COOK ENDOSCOPY W2795017

    Patients

    Seq Age Sex Outcome Treatment
    1 OLYMPUS GASTROSCOPE (UNKNOWN MODEL #)| COOK ENDOSCOPY DILATION SYRINGE (DS-60CC-S)