BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HERCULES 3 STAGE WIREGUIDED BALLOON ESOPHAGEAL-PYLORIC-COLONIC

    MDR report key: 3222110 · Received July 2, 2013

    Report

    Report Number
    1037905-2013-00498
    Event Type
    Malfunction
    Date Received
    July 2, 2013
    Date of Event
    June 4, 2013
    Report Date
    June 4, 2013
    Manufacturer
    WILSON-COOK MEDICAL INC.
    Product Code
    KNQ
    PMA / PMN Number
    K090183
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION EVALUATION: OUR EVALUATION OF THE RETURNED PRODUCT CONFIRMED THE REPORT. THERE WAS AN APPROXIMATELY 1CM HOLE IN THE BALLOON. A FUNCTIONAL TEST TO INFLATE THE DEVICE WAS NOT POSSIBLE DUE TO THE SIZE OF THE HOLE IN THE BALLOON MATERIAL. THERE WAS NO PART OF THE BALLOON MATERIAL MISSING. THE HOLD HAD A FLAP OF MATERIAL ON THE DISTAL SIDE OF THE HOLE AS IF IT WAS RIPPED DURING EXTRACTION OF THE DEVICE. THERE WAS A KINK IN THE CATHETER APPROXIMATELY 123 CM FROM THE BALLOON. 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 AND CATHETER 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. 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 CATHETER PRESERVATION. KINKS AND/OR BENDS AND/OR CRACKS IN THE CATHETER CAN OCCUR IF THE DEVICE EXPERIENCES EXCESSIVE PRESSURE DURING USE AND/OR GENERAL HANDLING. THE INSTRUCTIONS FOR USE FOR THIS PRODUCT LINE ADVISE THE USER TO ADVANCE THE DEVICE THROUGH THE ACCESSORY CHANNEL IN SHORT INCREMENTS. THIS ACTIVITY WILL AID IN CATHETER PRESERVATION. PRIOR TO DISTRIBUTION, ALL HERCULES 3 STAGE ESOPHAGEAL-PYLORIC-COLONIC WIREGUIDED 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 ESOPHAGOGASTRODUODENOSCOPY (EGD) PROCEDURE, A COOK HERCULES 3 STAGE ESOPHAGEAL BALLOON WAS USED IN THE ESOPHAGUS. THE BALLOON WAS ADVANCED INTO POSITION AND INFLATED WITH WATER. THE BALLOON WAS INFLATED TO 18MM AND THERE WERE NO PROBLEMS. THE BALLOON WAS THEN INFLATED TO 20MM AND IT LEAKED. NO SECTION OF THE DEVICE DETACHED IN THE ENDOSCOPE OR PATIENT. ANOTHER DEVICE OF THE SAME TYPE WAS USED TO FINISH THE PROCEDURE. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT'S 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
    300334 HERCULES 3 STAGE WIREGUIDED BALLOON ESOPHAGEAL-PYLORIC-COLONIC KNQ, DILATOR, ESOPHAGEAL KNQ WILSON-COOK MEDICAL INC. W3247878

    Patients

    Seq Age Sex Outcome Treatment
    1 COOK DS-60CC-S INFLATION SYRINGE| OLYMPUS ENDOSCOPE: MODEL #UNK