BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HERCULES 3 STAGE WIREGUIDED BALLOON ESOPHAGEAL-PYLORIC-COLONIC

    MDR report key: 10959526 · Received December 7, 2020

    Report

    Report Number
    1037905-2020-00533
    Event Type
    Malfunction
    Date Received
    December 7, 2020
    Report Date
    December 7, 2020
    Manufacturer
    COOK ENDOSCOPY
    Product Code
    KNQ
    UDI-DI
    10827002517971
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INITIAL REPORTER OCCUPATION: EQUIPMENT COORDINATOR. INVESTIGATION EVALUATION: OUR EVALUATION OF THE PRODUCT SAID TO BE INVOLVED CONFIRMED THE REPORT. A VISUAL EVALUATION OF THE PRODUCT RECEIVED CONFIRMED THAT THE BLUE CATHETER HAD BROKEN AT THE 18.5 CM LOCATION AND CRACKED AT THE 21.5 CM LOCATION AS MEASURED FROM THE DISTAL TIP OF THE BALLOON. NO OTHER KINKS, CRACKS OR ANY OTHER DAMAGE WAS IDENTIFIED ON 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 WIRE GUIDED BALLOONS ESOPHAGEAL-PYLORIC-COLONIC ARE SUBJECTED TO A 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. 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

    WHILE PREPARING FOR AN ESOPHAGOGASTRODUODENOSCOPY (EGD), THE PHYSICIAN OPENED A HERCULES 3 STAGE WIRE GUIDED BALLOON ESOPHAGEAL-PYLORIC-COLONIC. WHEN REMOVING THE DEVICE FROM THE PACKAGE, THE PHYSICIAN NOTICED THAT THE CATHETER WAS BROKEN IN TWO (2) PLACES. ANOTHER OF THE SAME DEVICE WAS USED TO COMPLETE THE PROCEDURE. ADDITIONAL INFORMATION WAS RECEIVED ON 20-NOV-2020 WHICH STATES THAT THE BALLOON WAS NEVER INFLATED. THE PLASTIC CASING AROUND THE WIRE WAS BROKEN/CRACKED IN TWO (2) PLACES DOWN TOWARDS THE BALLOON END [CATHETER IS BROKEN NEAR PATIENT END]. THE SURGEON SAW THE BROKEN PARTS PRIOR TO USING IT ON THE PATIENT AND ASKED US TO OPEN A NEW BALLOON. IT WAS INTENDED TO BE USED IN THE ESOPHAGUS. THIS OCCURRED PRIOR TO PATIENT CONTACT; THERE WAS NO IMPACT TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1426753 HERCULES 3 STAGE WIREGUIDED BALLOON ESOPHAGEAL-PYLORIC-COLONIC KNQ, ESOPHAGEAL DILATOR KNQ COOK ENDOSCOPY W4274260 10827002517971

    Patients

    Seq Age Sex Outcome Treatment
    1