BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HERCULES 3 STAGE WIREGUIDED BALLOON ESOPHAGEAL-PYLORIC-COLONIC

    MDR report key: 3252342 · Received July 24, 2013

    Report

    Report Number
    1037905-2013-00572
    Event Type
    Malfunction
    Date Received
    July 24, 2013
    Date of Event
    June 21, 2013
    Report Date
    June 24, 2013
    Manufacturer
    WILSON-COOK MEDICAL INC
    Product Code
    KNQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION EVAL: OUR EVAL OF THE RETURNED PRODUCT CONFIRMED THE REPORT. THERE WAS AN APPROX 6CM SPLIT IN THE BALLOON. THE DEVICE COULD NOT BE INFLATED DUE TO THE CONDITION OF THE RETURNED DEVICE. THERE WAS NO PART OF THE BALLOON MATERIAL MISSING. A PRODUCT-SPECIFIC DISCREPANCY THAT COULD HAVE CAUSED OR CONTRIBUTED TO THIS OBSERVATION WAS NOT OBSERVED DURING OUR LAB 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 LAB SETTING. DUE TO A VARIETY OF CLINICAL CONDITIONS, SUCH AS PT ANATOMY, ENDOSCOPE POSITIONS OR PROGRESSION OF DISEASE STATE, WE COULD NOT REPRODUCE THE ACTUAL CONDITIONS OF PRODUCT USAGE DURING OUR LAB 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 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 PRECAUTIONS: "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-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 THE PROCEDURE, A COOK HERCULES 3 STAGE WIREGUIDED BALLOON WAS USED IN THE ESOPHAGUS. THE BALLOON WAS ADVANCED THROUGH THE ENDOSCOPE AND INFLATED WITH WATER. THE BALLOON WAS INFLATED AND DEFLATED TWICE. THE BALLOON BURST DURING THE PROCEDURE AND STARTED TO LEAK. THE BALLOON MANAGED TO REACH 18MM WITH NO PROBLEM, BUT WHEN THE BALLOON REACHED 19MM, IT RUPTURED. NO SECTION OF THE DEVICE DETACHED INSIDE THE PT OR ENDOSCOPE. THEY OPENED UP ANOTHER BALLOON AND THE PROCEDURE CONTINUED WITH NO PROBLEMS. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PT'S BODY. OTHER THAN USING ANOTHER BALLOON TO FINISH THE PROCEDURE, THE PT DID NOT REQUIRE ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    344384 HERCULES 3 STAGE WIREGUIDED BALLOON ESOPHAGEAL-PYLORIC-COLONIC KNQ, DIALTOR, ESOPHAGEAL KNQ WILSON-COOK MEDICAL INC W3196443

    Patients

    Seq Age Sex Outcome Treatment
    1 ALLAINCE INFLATION DEVICE| ENDOSCOPE (UNK MODEL NUMBER)