BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HERCULES 100 3 STAGE WIRE GUIDED BALLOON

    MDR report key: 11398455 · Received March 2, 2021

    Report

    Report Number
    1037905-2021-00091
    Event Type
    Injury
    Date Received
    March 2, 2021
    Date of Event
    January 29, 2021
    Report Date
    April 14, 2021
    Manufacturer
    COOK ENDOSCOPY
    Product Code
    KCF
    UDI-DI
    00827002352711
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    CONTINUED FROM SUSPECT MEDICAL DEVICES. COMMON NAME: DILATOR, ESOPHAGEAL. PRODUCT CODE: KCF. 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. THE USER STATED "THE PROCEDURE WENT AS INTENDED AND THE BALLOONS WERE USED WITHOUT ANY DIFFICULTY". A DEVICE FAILURE WAS NOT IDENTIFIED IN OUR REVIEW OF THE PROVIDED INFORMATION. THIS EVENT APPEARS TO BE A CLINICAL COMPLICATION OF THE PROCEDURE. 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. 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 Manufacturer Narrative · 0

    CONTINUED FROM SUSPECT MEDICAL DEVICES COMMON NAME: DILATOR, ESOPHAGEAL PRODUCT CODE: KCF CORRECTION- THE SUMMARY REPORT DESIGNATION IS INCORRECT, THE REPORT IS NOT A SUMMARY REPORT. 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. THE USER STATED "THE PROCEDURE WENT AS INTENDED AND THE BALLOONS WERE USED WITHOUT ANY DIFFICULTY". A DEVICE FAILURE WAS NOT IDENTIFIED IN OUR REVIEW OF THE PROVIDED INFORMATION. THIS EVENT APPEARS TO BE A CLINICAL COMPLICATION OF THE PROCEDURE. 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. 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 Manufacturer Narrative · 1

    CONTINUED FROM SUSPECT MEDICAL DEVICES: COMMON NAME: DILATOR, ESOPHAGEAL. PRODUCT CODE: KCF. THE INVESTIGATION IS CURRENTLY IN PROGRESS. A FOLLOW-UP EMDR WILL BE SENT FOLLOWING THE COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    DURING AN ESOPHAGEAL DILATION PROCEDURE, THE PHYSICIAN USED A HERCULES 100 3 STAGE WIRE GUIDED BALLOON. THE PROCEDURE WENT AS INTENDED AND WAS COMPLETED WITH DILATION BEING COMPLETED IN THREE (3) INCREMENTAL STEPS TO ACHIEVE 20 MM OF DILATION. THE BALLOON WAS USED WITHOUT ANY DIFFICULTY AND WORKED APPROPRIATELY BOTH INFLATING AND RAPIDLY DEFLATING THROUGHOUT THE CASE. THERE WERE NOT ANY AREAS OF CONCERN THAT WERE SEEN OR DISCUSSED DURING OR POST CASE. ONE WEEK AFTER THE PROCEDURE, THE PHYSICIAN HAD A FOLLOW UP WITH THE PATIENT WHO HAD DEVELOPED SEVERE SUPRAGLOTTIC SWELLING ABOVE THE DILATION SITE. ADDITIONAL INFORMATION RECEIVED FROM THE PHYSICIAN STATES THAT HE BELIEVED THE BALLOON WAS INFLATED WITH WATER TO THE SPECIFIED ATM FOR 20 MM OF DILATION. THERE WAS NO DIFFICULTY WITH ACCESS OR ADVANCING THE ENDOSCOPE. NO NEGATIVE PRESSURE WAS APPLIED TO THE BALLOON AND WE USED A RIGID ENDOSCOPE THROUGH THE MOUTH (NOT A FLEXIBLE ENDOSCOPE VIA A CHANNEL). NO LUBRICATION WAS USED, BUT THIS WAS NOT A CHANNELED INSERTION. THE SUPRAGLOTTIC SWELLING WAS TREATED WITH ANTIBIOTICS, STEROIDS, AND INTENSIVE CARE UNIT (ICU) OBSERVATION. AIRWAY SYMPTOMS STARTED ABOUT FIVE (5) DAYS AFTER SURGERY. PATIENT RESPONDED QUICKLY. ON HIS LAST EXAM, THE SWELLING HAD SIGNIFICANTLY IMPROVED, BUT NOT RESOLVED. THE PHYSICIAN IS UNCERTAIN IF THE COOK DEVICE HAD ANYTHING TO DO WITH THE SUPRAGLOTTIC SWELLING AS IT WAS NOT IN THE SURGICAL FIELD DURING DILATION. THE PHYSICIAN STATED THAT MOST LIKELY THE SWELLING WAS FROM THE LARYNGOSCOPE, HOWEVER, IN HIS YEARS OF PRACTICE AS A PRIMARY LARYNGEAL AIRWAY PHYSICIAN, HE HAS NOT SEEN A SIMILAR COMPLICATION IN THIS PARTICULAR CIRCUMSTANCE. DUE TO THE UNCERTAINTY AND OUT OF CAUTION, A REPORT IS BEING SENT AS THE COOK DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE SERIOUS INJURY THAT OCCURRED. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT REQUIRED STEROIDS, ANTIBIOTICS, AND OBSERVATION IN THE INTENSIVE CARE UNIT DUE TO SUPRAGLOTTIC SWELLING THAT DEVELOPED FOLLOWING THE PROCEDURE. OTHER THAN THE SWELLING AND AIRWAY SYMPTOMS, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    296468 HERCULES 100 3 STAGE WIRE GUIDED BALLOON KCF COOK ENDOSCOPY W4380877 00827002352711

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R COOK SPHERE INFLATION DEVICE, CID-60-15| LARYNGOSCOPE, UNKNOWN MAKE OR MODEL