BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HERCULES 3 STAGE WIREGUIDED BALLOON ESOPHAGEAL-PYLORIC-COLONIC

    MDR report key: 8695530 · Received June 13, 2019

    Report

    Report Number
    1037905-2019-00322
    Event Type
    Malfunction
    Date Received
    June 13, 2019
    Date of Event
    May 7, 2019
    Report Date
    May 10, 2019
    Manufacturer
    COOK ENDOSCOPY
    Product Code
    KNQ
    UDI-DI
    00827002517981
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION EVALUATION: OUR LABORATORY EVALUATION OF THE PRODUCT SAID TO BE INVOLVED DETERMINED THERE WAS A CRACK IN THE CATHETER. DURING A VISUAL EXAMINATION, A CRACK WAS OBSERVED APPROXIMATELY 118.2 CM FROM THE DISTAL END. KINKS WERE ALSO OBSERVED IN THE CATHETER APPROXIMATELY 115.4 CM, 116.2 CM AND 124.8 CM FROM THE DISTAL END. THE PRE-LOADED WIRE GUIDE WAS ALSO KINKED APPROXIMATELY 1.3 CM FROM THE DISTAL END (USER END) AND THE WHITE PLASTIC CAP LOCATED AT THE PROXIMAL END OF THE WIRE GUIDE WAS MISSING AND NOT INCLUDED IN THE RETURN. A PRODUCT-SPECIFIC DISCREPANCY THAT COULD HAVE CAUSED OR CONTRIBUTED TO THIS OBSERVATION WAS NOT OBSERVED DURING OUR LABORATORY ANALYSIS. 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: 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 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 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

    IN PREPARATION FOR A PROCEDURE, THE USER SELECTED A COOK HERCULES 3 STAGE WIREGUIDED BALLOON ESOPHAGEAL-PYLORIC-COLONIC (HBD-W-18-19-20). THE CATHETER WAS KINKED WHEN THE PRODUCT WAS TAKEN OUT OF THE PACKAGE. [THEY] USED ANOTHER HBD-W WITHOUT ANY PROBLEM. THERE WAS NO REPORTABLE INFORMATION AT THIS TIME. THE DEVICE WAS EVALUATED ON 29-MAY-2019: A CRACK IN THE CATHETER WAS OBSERVED APPROXIMATELY 118.2 CM FROM THE DISTAL END (SUBJECT OF THIS REPORT). THIS OCCURRED PRIOR TO PATIENT CONTACT; THERE WAS NO IMPACT TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    492009 HERCULES 3 STAGE WIREGUIDED BALLOON ESOPHAGEAL-PYLORIC-COLONIC KNQ, DILATOR, ESOPHAGEAL KNQ COOK ENDOSCOPY G51798 W4175989 00827002517981

    Patients

    Seq Age Sex Outcome Treatment
    1