BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HERCULES 100 3 STAGE WIRE GUIDED BALLOON

    MDR report key: 16826983 · Received April 27, 2023

    Report

    Report Number
    1037905-2023-00191
    Event Type
    Malfunction
    Date Received
    April 27, 2023
    Date of Event
    April 4, 2023
    Report Date
    April 27, 2023
    Manufacturer
    WILSON-COOK MEDICAL INC
    Product Code
    KCF
    UDI-DI
    00827002352711
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION EVALUATION: A PRODUCT EVALUATION WAS NOT PERFORMED IN RESPONSE TO THIS REPORT BECAUSE THE PRODUCT SAID TO BE INVOLVED WAS NOT PROVIDED TO COOK FOR EVALUATION. THE REPORT COULD NOT BE CONFIRMED. 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 CONCLUSION: WE COULD NOT CONDUCT A COMPLETE INVESTIGATION BECAUSE THE PRODUCT SAID TO BE INVOLVED WAS NOT RETURNED FOR EVALUATION. A DEFINITIVE CAUSE FOR THE REPORTED OBSERVATION COULD NOT BE DETERMINED. THE REPORT INDICATES THAT NEGATIVE PRESSURE WAS NOT APPLIED TO THE DEVICE PRIOR TO ADVANCEMENT THROUGH THE ENDOSCOPE. A POSSIBLE CONTRIBUTING FACTOR TO A LEAK IN THE BALLOON MATERIAL IS FAILURE TO APPLY NEGATIVE PRESSURE TO THE BALLOON DILATOR PRIOR TO ADVANCEMENT THROUGH THE ENDOSCOPE. NEGATIVE PRESSURE WILL ALSO AID IN BALLOON PRESERVATION AND OPTIMIZE BALLOON PERFORMANCE. THE INSTRUCTIONS FOR USE DIRECT THE USER: "APPLY NEGATIVE PRESSURE TO THE DEVICE TO FACILITATE REMOVAL OF THE PROTECTIVE SLEEVE." IN ADDITION, THE USER IS FURTHER INSTRUCTED TO: "MAINTAIN NEGATIVE PRESSURE AND INTRODUCE THE DEVICE OVER THE WIRE GUIDE, ADVANCING IN SHORT INCREMENTS UNTIL THE BALLOON IS COMPLETELY VISUALIZED ENDOSCOPICALLY." THE APPLICATION OF NEGATIVE PRESSURE WILL ASPIRATE ALL RESIDUAL AIR FROM THE BALLOON AND EASE ENDOSCOPIC ADVANCEMENT. IN ADDITION, IT WAS REPORTED THE DEVICE WAS MAKING CONTACT WITH A METALLIC DEVICE DURING USE, THIS COULD HAVE CONTRIBUTED TO CREATING A LEAK IN THE BALLOON. PRIOR TO DISTRIBUTION, ALL HERCULES 100 3 STAGE WIRE GUIDED 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: A REVIEW OF THE COMPLAINT HISTORY WAS CONDUCTED AND THIS REPRESENTS AN ISOLATED OCCURRENCE. THE LIKELIHOOD OF OCCURRENCE IS CONSIDERED RARE. 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. ADDITIONAL COMMENTS REGARDING THIS REPORT: BASED ON THE INFORMATION PROVIDED THAT NEGATIVE PRESSURE WAS NOT APPLIED, A COOK REPRESENTATIVE HAS BEEN DIRECTED TO CONTACT THE MEDICAL FACILITY INVOLVED IN AN EFFORT TO PROMOTE FURTHER EDUCATION AND UNDERSTANDING RELATED TO APPROPRIATE USAGE OF THIS PRODUCT.

    Description of Event or Problem · 0

    DURING A TRANSORAL ESOPHAGEAL DILATION, THE PHYSICIAN USED A COOK HERCULES 100 3 STAGE WIRE GUIDED BALLOON. IT WAS REPORTED [THAT] THE BALLOON BLEW UP TO THE FIRST STAGE AT 2 ATM AND THEN THEY TOOK THE BALLOON OUT, REINSERTED AND INFLATED TO THE 2ND STAGE AT 4 ATM. THE USER STATED "THE BALLOON WAS HITTING THE TRANSORAL METAL INSERTER WHEN INFLATED (NOT SURE IF THIS IS WHAT IT'S CALLED) AND STARTED BEING UNABLE TO HOLD THE ATM". THEY DEFLATED AND TOOK OUT THE BALLOON. BLEW UP THE BALLOON OUTSIDE OF THE PATIENT AND THERE WAS A SMALL HOLE IN THE BALLOON. THE USER EXPLAINED THAT THEY THINK IT IS DUE TO THE BALLOON HITTING THE METAL INSERTER BUT FEELS THERE IS NO WAY TO BE SURE. 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
    1206312 HERCULES 100 3 STAGE WIRE GUIDED BALLOON DILATOR, ESOPHAGEAL KCF WILSON-COOK MEDICAL INC G35271 W4518632 00827002352711

    Patients

    Seq Age Sex Outcome Treatment
    1 Male ENDOSCOPE - TRANSORAL RIGID SCOPE & LARYNGOSCOPE