BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HERCULES 3 STAGE WIREGUIDED BALLOON ESOPHAGEAL-PYLORIC-COLONIC

    MDR report key: 9597551 · Received January 16, 2020

    Report

    Report Number
    1037905-2020-00029
    Event Type
    Malfunction
    Date Received
    January 16, 2020
    Date of Event
    December 12, 2019
    Report Date
    December 20, 2019
    Manufacturer
    COOK ENDOSCOPY
    Product Code
    KNQ
    UDI-DI
    00827002517974
    PMA / PMN Number
    K061937
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    INFORMATION REGARDING SECTION E3: NON-HEALTHCARE PROFESSIONAL. INVESTIGATION EVALUATION: A PRODUCT EVALUATION WAS PERFORMED ONLY BY THE PICTURES PROVIDED WITH THIS REPORT BECAUSE THE PRODUCT SAID TO BE INVOLVED WAS NOT PROVIDED TO COOK FOR EVALUATION. A PHOTO OF THE LOT NUMBER WAS NOT PROVIDED. THE REPORT WAS CONFIRMED BASED ON THE TWO PHOTOS PROVIDED TO AID THE INVESTIGATION. IN THE PHOTOS, IT APPEARS THAT THE CATHETER HAS CRACKED IN ONE LOCATION AND BROKEN IN ANOTHER LOCATION. THE LOCATION OF THE CRACKS/BREAKS ON THE CATHETER COULD NOT BE DETERMINED WITHOUT RETURN OF THE COMPLAINT 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: A CORRECTIVE ACTION HAS BEEN INITIATED TO REDUCE OCCURRENCES OF CATHETER CRACKING, SPLITTING OR BREAKING FOR HBD-W DEVICES. REFERENCE CAPA 261610. THE PRODUCT SAID TO BE INVOLVED IS INCLUDED IN THE SCOPE OF THE CORRECTIVE ACTIONS. POSSIBLE CONTRIBUTING FACTORS BASED ON THE RESPONSES RECEIVED TO THE ADDITIONAL QUESTIONS INCLUDE THE FACT THAT THE BALLOON WAS INFLATED PRIOR TO PATIENT CONTACT. THE IFU STATES: "DO NOT PRE-INFLATE THE BALLOON." IN ADDITION, THE USER INDICATED THAT A 20ML (CC) SYRINGE WITH AN ATM/PSI WITH A METER WAS USED TO INFLATE THE BALLOON. THE INSTRUCTIONS FOR USE STATE: "ATTACH THE BALLOON TO A 60 ML (CC) INFLATION DEVICE WITH GAUGE TO MONITOR BALLOON PRESSURE." PRIOR TO DISTRIBUTION, ALL HERCULES 3 STAGE WIREGUIDED BALLOONS ESOPHAGEAL-PYLORIC-COLONIC ARE SUBJECTED TO A VISUAL EXAMINATION 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. THE LIKELIHOOD OF OCCURRENCE IS CONSIDERED RARE. A CORRECTIVE ACTION HAS BEEN INITIATED IN AN EFFORT TO REDUCE OCCURRENCES OF THIS NATURE. THIS PRODUCT WAS MANUFACTURED PRIOR TO IMPLEMENTATION OF THIS CORRECTIVE ACTION. 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 THE BALLOON WAS INFLATED PRIOR TO PATIENT CONTACT AND THE USER INDICATED THAT A 20ML (CC) SYRINGE WITH AN ATM/PSI WITH A METER WAS USED TO INFLATE THE BALLOON, 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 ESOPHAGOGASTRODUODENOSCOPY (EGD), THE PHYSICIAN USED A COOK HERCULES 3 STAGE WIREGUIDED BALLOON. THE GUIDE [CATHETER] BENT AND BROKE DURING INSERTION OF THE BALLOON. 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. ADDITIONAL INFORMATION WAS PROVIDED ON 12-FEB 2020 THAT INDICATED THE BALLOON WAS TESTED PRIOR TO USE AND A 20ML (CC) SYRINGE WITH AN ATM/PSI WITH A METER WAS USED TO INFLATE THE BALLOON [AGAINST THE INSTRUCTIONS FOR USE]. 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.

    Additional Manufacturer Narrative · 1

    OCCUPATION: NON-HEALTHCARE PROFESSIONAL. INVESTIGATION EVALUATION: A PRODUCT EVALUATION WAS PERFORMED ONLY BY THE PICTURES PROVIDED WITH THIS REPORT BECAUSE THE PRODUCT SAID TO BE INVOLVED WAS NOT PROVIDED TO COOK FOR EVALUATION. A PHOTO OF THE LOT NUMBER WAS NOT PROVIDED. THE REPORT WAS CONFIRMED BASED ON THE TWO PHOTOS PROVIDED TO AID THE INVESTIGATION. IN THE PHOTOS, IT APPEARS THAT THE CATHETER HAS CRACKED IN ONE LOCATION AND BROKEN IN ANOTHER LOCATION. THE LOCATION OF THE CRACKS/BREAKS ON THE CATHETER COULD NOT BE DETERMINED WITHOUT RETURN OF THE COMPLAINT 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: A CORRECTIVE ACTION HAS BEEN INITIATED TO REDUCE OCCURRENCES OF CATHETER CRACKING, SPLITTING OR BREAKING FOR HBD-W DEVICES. THE PRODUCT SAID TO BE INVOLVED IS INCLUDED IN THE SCOPE OF THE CORRECTIVE ACTIONS. PRIOR TO DISTRIBUTION, ALL HERCULES 3 STAGE WIREGUIDED BALLOONS ESOPHAGEAL-PYLORIC-COLONIC ARE SUBJECTED TO A VISUAL EXAMINATION 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. THE LIKELIHOOD OF OCCURRENCE IS CONSIDERED RARE. A CORRECTIVE ACTION HAS BEEN INITIATED IN AN EFFORT TO REDUCE OCCURRENCES OF THIS NATURE. THIS PRODUCT WAS MANUFACTURED PRIOR TO IMPLEMENTATION OF THIS CORRECTIVE ACTION. 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), THE PHYSICIAN USED A COOK HERCULES 3 STAGE WIREGUIDED BALLOON. THE GUIDE [CATHETER] BENT AND BROKE DURING INSERTION OF THE BALLOON. 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
    57699 HERCULES 3 STAGE WIREGUIDED BALLOON ESOPHAGEAL-PYLORIC-COLONIC KNQ, DILATOR, ESOPHAGEAL KNQ COOK ENDOSCOPY G51797 W4117886 00827002517974

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR