BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HERCULES 100 3 STAGE WIRE GUIDED BALLOON

    MDR report key: 18798057 · Received February 28, 2024

    Report

    Report Number
    1037905-2024-00115
    Event Type
    Malfunction
    Date Received
    February 28, 2024
    Date of Event
    February 2, 2024
    Report Date
    February 28, 2024
    Manufacturer
    WILSON-COOK MEDICAL INC
    Product Code
    KCF
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INFORMATION REGARDING SUSPECT MEDICAL DEVICE SECTION: COMMON DEVICE NAME: DILATOR, ESOPHAGEAL. PRODUCT CODE: KCF. INVESTIGATION EVALUATION: THE PRODUCT SAID TO BE INVOLVED WAS RETURNED IN AN OPEN POUCH FROM THE LOT NUMBER PROVIDED IN THE REPORT. THE LABEL MATCHES THE PRODUCT RETURNED. OUR LABORATORY EVALUATION OF THE PRODUCT SAID TO BE INVOLVED CONFIRMED THE REPORT. THE BALLOON WAS RETURNED WITH NO SIGN OF DAMAGE TO THE CATHETER. A VISUAL INSPECTION OF THE BALLOON IDENTIFIED A RUPTURE IN THE MIDDLE OF THE BALLOON MATERIAL. NO OTHER ANOMALIES WERE DETECTED WITH THE DEVICE. 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: OUR EVALUATION OF THE RETURNED DEVICE CONFIRMED THE REPORT. A DEFINITIVE CAUSE FOR THE REPORTED OBSERVATION COULD NOT BE DETERMINED BECAUSE THE CONDITION OF THE PRODUCT SAID TO BE INVOLVED PROHIBITED A COMPLETE EVALUATION. A DISCREPANCY OR ANOMALY THAT COULD HAVE CONTRIBUTED TO THE REPORTED OBSERVATION WAS NOT OBSERVED DURING OUR LABORATORY ANALYSIS OF THE RETURNED PRODUCT. THE REPORT INDICATES THAT NEGATIVE PRESSURE WAS NOT APPLIED TO THE BALLOON PRIOR TO ADVANCEMENT THROUGH THE ENDOSCOPE. NEGATIVE PRESSURE WILL 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. 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: BASED ON THE INFORMATION PROVIDED THAT NEGATIVE PRESSURE WAS NOT APPLIED TO THE BALLOON PRIOR TO ADVANCEMENT THROUGH THE ENDOSCOPE, 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 AN ESOPHAGOSCOPY, THE PHYSICIAN USED A COOK HERCULES 100 3 STAGE WIRE GUIDED BALLOON. IT WAS REPORTED [THAT] WHILE DILATING THE PATIENT, THE HERCULES BALLOON RUPTURED. 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
    451404 HERCULES 100 3 STAGE WIRE GUIDED BALLOON DILATOR, ESOPHAGEAL KCF WILSON-COOK MEDICAL INC W4689603

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Female UNKNOWN ENDOSCOPE.