BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HERCULES 3 STAGE WIREGUIDED BALLOON ESOPHAGEAL-PYLORIC-COLONIC

    MDR report key: 10353055 · Received July 31, 2020

    Report

    Report Number
    1037905-2020-00305
    Event Type
    Malfunction
    Date Received
    July 31, 2020
    Date of Event
    July 3, 2020
    Report Date
    September 15, 2020
    Manufacturer
    COOK ENDOSCOPY
    Product Code
    KNQ
    UDI-DI
    10827002517964
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GB
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    CONTINUED FROM CONCOMITANT PRODUCTS: BOSTON SCIENTIFIC ALLIANCE INFLATION GUN, MODEL UNKNOWN. INITIAL REPORTER OCCUPATION: UNKNOWN. INVESTIGATION EVALUATION: OUR LABORATORY EVALUATION OF THE PRODUCT SAID TO BE INVOLVED CONFIRMED THE REPORT. THE DEVICE RETURNED WITH THE BLUE CATHETER BROKEN AND KINKED. THE BLUE SWITCH ASSEMBLY AND WIRE GUIDE WERE NOT INCLUDED WITH THE RETURN HOWEVER AN INFLATION DEVICE (BRAND UNKNOWN) WAS INCLUDED AS PART OF THE RETURN. A KINK WAS FOUND AT THE 89 CM LOCATION AND THE CATHETER WAS BROKEN AT THE 99.5 CM AREA AS MEASURED FROM THE DISTAL TIP. THE PURPLE SHEATH WAS EXPOSED AT THE LOCATION OF THE BREAK. THE PURPLE HUB WHERE THE BLUE SWITCH ASSEMBLY IS ATTACHED IS CRACKED. THE PHOTOS PROVIDED BY THE CUSTOMER ALSO CONFIRMED THE LOT NUMBER, THE BREAK IN THE CATHETER, AND A CRACK IN THE PURPLE LUER HUB. THE USER INDICATED THAT THEY HAD CONNECTED THE INFLATION DEVICE TO THIS PORT IN ERROR AND HAD ATTEMPTED TO INFLATE THE BALLOON. 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: 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 PRIOR TO DISTRIBUTION, ALL HERCULES 3 STAGE WIREGUIDED BALLOON ESOPHAGEAL-PYLORIC-COLONIC ARE SUBJECTED TO A VISUAL EXAMINATION AND LEAK TEST 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 · 0

    DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD), THE PHYSICIAN USED A COOK HERCULES 3 STAGE WIREGUIDED BALLOON ESOPHAGEAL-PYLORIC-COLONIC. THE NURSE OPENED THE EQUIPMENT AND ATTACHED THE CATHETER [INFLATION DEVICE] TO THE DILATOR AFTER REMOVING THE GUIDEWIRE AND PRIMING THE LINE [CATHETER]. ON INSERTION INTO THE PATIENT AND TRYING TO DILATE THE BALLOON, THE BALLOON FAILED TO DILATE. THE ENDOSCOPIST WAS NOTIFIED AND THE EQUIPMENT WAS REMOVED AND TESTED. THE NURSE REALIZED THEY CONNECTED THE CATHETER TO THE INCORRECT PORT. THE PHYSICIAN INSERTED THE CATHETER INTO THE CORRECT PORT AND CONTINUED THE PROCEDURE, BUT THE BALLOON DID NOT INFLATE. THE WATER WAS GOING INTO THE DEVICE, BUT THE BALLOON WAS NOT DILATING, CAUSING THE PATIENT TO COUGH. THE BALLOON WAS REMOVED AND A HOLE WAS FOUND IN THE CATHETER, WHICH CAUSE THE WATER LOSS AND BALLOON FAILURE. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. 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

    CONTINUED FROM CONCOMITANT PRODUCTS: BOSTON SCIENTIFIC ALLIANCE INFLATION GUN, MODEL UNKNOWN. INITIAL REPORTER OCCUPATION: UNKNOWN. INVESTIGATION EVALUATION: A PRODUCT EVALUATION WAS PERFORMED ONLY BY THE PICTURES PROVIDED WITH THIS REPORT BECAUSE THE PRODUCTS SAID TO BE INVOLVED WERE NOT PROVIDED TO COOK FOR EVALUATION. THE LOT NUMBER PROVIDED IN THE PHOTOS MATCHES THIS REPORT. THE LABEL IN THE PHOTO MATCHES THE PRODUCT REPORTED. THE REPORT WAS CONFIRMED WITH THE PHOTOS PROVIDED. A CRACK IN THE CATHETER EXPOSING THE INNER PURPLE SHEATH IS VISIBLE IN THE PICTURES. A CRACK IS ALSO VISIBLE IN THE LUER HUB OF THE WIRE GUIDE ASSEMBLY CONNECTION. THE USER INDICATED THAT THEY HAD CONNECTED THE INFLATION DEVICE TO THIS PORT IN ERROR AND HAD ATTEMPTED TO INFLATE THE BALLOON. 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 BALLOON ESOPHAGEAL-PYLORIC-COLONIC ARE SUBJECTED TO A VISUAL EXAMINATION AND LEAK TEST 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 ESOPHAGEAL-PYLORIC-COLONIC. THE NURSE OPENED THE EQUIPMENT AND ATTACHED THE CATHETER [INFLATION DEVICE] TO THE DILATOR AFTER REMOVING THE GUIDEWIRE AND PRIMING THE LINE [CATHETER]. ON INSERTION INTO THE PATIENT AND TRYING TO DILATE THE BALLOON, THE BALLOON FAILED TO DILATE. THE ENDOSCOPIST WAS NOTIFIED AND THE EQUIPMENT WAS REMOVED AND TESTED. THE NURSE REALIZED THEY CONNECTED THE CATHETER TO THE INCORRECT PORT. THE PHYSICIAN INSERTED THE CATHETER INTO THE CORRECT PORT AND CONTINUED THE PROCEDURE, BUT THE BALLOON DID NOT INFLATE. THE WATER WAS GOING INTO THE DEVICE BUT THE BALLOON WAS NOT DILATING, CAUSING THE PATIENT TO COUGH. THE BALLOON WAS REMOVED AND A HOLE WAS FOUND IN THE CATHETER, WHICH CAUSE THE WATER LOSS AND BALLOON FAILURE. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. 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
    814107 HERCULES 3 STAGE WIREGUIDED BALLOON ESOPHAGEAL-PYLORIC-COLONIC KNQ, DILATOR, ESOPHAGEAL KNQ COOK ENDOSCOPY W4312066 10827002517964

    Patients

    Seq Age Sex Outcome Treatment
    1 OLYMPUS GASTROSCOPE, UNKNOWN MODEL.