BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLON DECOMPRESSION SET

    MDR report key: 15751175 · Received November 8, 2022

    Report

    Report Number
    3001845648-2022-00749
    Event Type
    Malfunction
    Date Received
    November 8, 2022
    Report Date
    October 10, 2022
    Manufacturer
    COOK IRELAND LTD
    Product Code
    FEG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    PMA/510(K) # K171619. DEVICE EVALUATION: THE CDSG-14-175 DEVICE OF UNKNOWN LOT NUMBER INVOLVED IN THIS COMPLAINT WAS NOT AVAILABLE FOR EVALUATION. WITH THE INFORMATION PROVIDED, A DOCUMENT-BASED INVESTIGATION WAS CONDUCTED. LAB EVALUATION THE DEVICE EVALUATION COULD NOT BE COMPLETED AS THE DEVICE OR PHOTOGRAPHIC EVIDENCE OF THE DEVICE WAS NOT RETURNED FOR EVALUATION. DOCUMENT REVIEW MANUFACTURING RECORDS REVIEW COULD NOT BE COMPLETED AS THE LOT NUMBER IS UNKNOWN. HOWEVER, PRIOR TO DISTRIBUTION ALL CDSG-14-175 DEVICES ARE SUBJECT TO VISUAL A VISUAL INSPECTION AND FUNCTIONAL CHECKS TO ENSURE DEVICE INTEGRITY. THESE INSPECTIONS AND FUNCTIONAL CHECKS ARE OUTLINED IN INTERNAL PROCEDURES IN PLACE AT CIRL. REVIEW OF HISTORICAL DATA: HISTORICAL DATA WAS NOT REVIEWED AS THE LOT NUMBER IS UNKNOWN. THE INSTRUCTIONS FOR USE, STATES THE FOLLOWING IN RELATION TO THE INTENDED USE OF THE DEVICE: ¿THE DEVICE IS INTENDED FOR TREATMENT OF ACUTE NON-TOXIC MEGACOLON, PSEUDO-OBSTRUCTION (OGILVIE'S SYNDROME) AND COLONIC STRICTURES." THERE IS EVIDENCE TO SUGGEST THAT THE CUSTOMER DID NOT FOLLOW THE INSTRUCTIONS FOR USE. ROOT CAUSE REVIEW A DEFINITIVE ROOT CAUSE OF OFF LABEL USE WAS DETERMINED. IT IS KNOWN THAT THE DEVICE WAS USED IN THE VOLVULUS. THE INSTRUCTIONS FOR USE STATE THAT THE INTENDED USE FOR THE DEVICE IS FOR THE TREATMENT OF ACUTE NON-TOXIC MEGACOLON, PSEUDO-OBSTRUCTION (OGILVIE'S SYNDROME) AND COLONIC STRICTURES. THE USE OF THE CDSG DEVICE IN THE VOLVULUS IS OFF LABEL USE. SUMMARY COMPLAINT IS CONFIRMED BASED ON CUSTOMER AND/OR REP TESTIMONY. MIGRATION WAS THE FAILURE IDENTIFIED IN THIS COMPLAINT EVENT. A POSSIBLE ROOT CAUSE IS ATTRIBUTED TO INHERENT RISK OF THE DEVICE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE. A REPLACEMENT DEVICE WAS REQUIRED, DURING THE SAME PROCEDURE. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR POTENTIAL EMERGING TRENDS.

    Description of Event or Problem · 0

    AS REPORTED TO CUSTOMER RELATIONS VIA CRI FORM "THE INITIAL CDSG-14-175 DEVICE WAS REPORTED TO HAVE MIGRATED 9 HOURS AFTER THE INITIAL PLACEMENT PROCEDURE, HOWEVER, THE SITE REPORTED THAT THE INITIAL DEVICE WAS REMOVED 7 HOURS AFTER PLACEMENT. THIS DISCREPANCY WAS NOT QUERIED. THE EVENT WAS REPORTED AS NOT RELATED TO THE COLON DECOMPRESSION SET AND RELATED TO THE STUDY PROCEDURE. THE SITE NOTED, ¿DESPITE MULTIPLE ATTEMPTS, THE DECOMPRESSION TUBE TRANSVERSED THE DISTAL END OF THE VOLVULUS, BUT NOT THE PROXIMAL MOST END, LEAVING THE TIP WITHIN THE VOLVULUS ITSELF. THE COLONOSCOPY WAS TECHNICALLY DIFFICULT. AND COMPLEX DUE TO UNSATISFACTORY BOWEL PREP, POOR ENDOSCOPIC VISUALIZATION AND SIGNIFICANT LOOPING, AND COULD NOT DECOMPRESS THE LUMEN SUCCESSFULLY. SO HE UNDERWENT ANOTHER PROCEDURE AND REPLACING ANOTHER TUBE AGAIN." FINAL PMCF REPORT RECEIVED ON (B)(6) 2022. IT WAS CONFIRMED BY MEDICAL AFFAIRS THAT THE USE OF CDSG DEVICE IN THE VOLVULUS IS OFF LABEL USE. TREATMENT WAS ENDOSCOPIC AND INCLUDED A SECOND PROCEDURE ¿TO DECOMPRESS THE VOLVULUS AND PLACE ANOTHER SET OF TUBE.¿ THE INITIAL DEVICE WAS REPORTED TO BE REMOVED AT 7 HOURS (AS STATED ABOVE, DISCREPANCY IN TIMING OF REMOVAL AND MIGRATION WAS NOT QUERIED) AFTER INITIAL PLACEMENT PROCEDURE AND WAS REPLACED WITH AN ADDITIONAL CDSG-14-175 DEVICE. THE SECOND DEVICE WAS REMOVED AT 72 HOURS AFTER PLACEMENT AND WAS NOT REPLACED. TREATMENT WITH THE COLON DECOMPRESSION SET WAS CONSIDERED NOT SUCCESSFUL. NO OTHER ADVERSE EVENTS WERE REPORTED PRIOR TO THE PATIENT BEING EXITED FROM THE STUDY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2378399 COLON DECOMPRESSION SET FEG TUBE, DOUBLE LUMEN FOR INTESTINAL DECOMPRESSION AND/OR INTUBATION FEG COOK IRELAND LTD UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Female