BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLON DECOMPRESSION SET

    MDR report key: 15751380 · Received November 8, 2022

    Report

    Report Number
    3001845648-2022-00753
    Event Type
    Malfunction
    Date Received
    November 8, 2022
    Report Date
    November 11, 2022
    Manufacturer
    COOK IRELAND LTD
    Product Code
    FEG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PMA/510(K) # K171619 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. THE DEVICE EVALUATION COULD NOT BE COMPLETED AS THE DEVICE OR PHOTOGRAPHIC EVIDENCE OF THE DEVICE WAS NOT RETURNED FOR EVALUATION. 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. AN IMAGE WAS NOT RETURNED FOR EVALUATION. 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. COMPLAINT IS CONFIRMED BASED ON CUSTOMER AND/OR REP TESTIMONY. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR POTENTIAL EMERGING TRENDS.

    Additional Manufacturer Narrative · 0

    PMA/510(K) # K171619. INVESTIGATION IS STILL PENDING, A FOLLOW UP MDR WILL BE SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS.

    Description of Event or Problem · 0

    SUPPLEMENTAL REPORT IS BEING SUBMITTED DUE TO THE COMPLETION OF THE INVESTIGATION ON 11-NOV-22.

    Description of Event or Problem · 0

    AS REPORTED TO CUSTOMER RELATIONS VIA CRI FORM "IN NOVEMBER 2020, THE PATIENT HAD CDSM-8.5 PLACED DUE TO A SIGMOID VOLVULUS. TWENTY-FOUR HOURS POST-PLACEMENT THE DEVICE MIGRATED. THIS WAS REPORTED AS RELATED TO THE COLON DECOMPRESSION SET AND A DEVICE DEFICIENCY, DESCRIBED AS THE INABILITY TO REMAIN WITHIN THE DILATED COLON. THE TUBE WAS REPLACED WITH CDSG-14-175. THIS DEVICE WAS REPORTED TO HAVE MIGRATED WITHIN 48 HOURS (OF THE PLACEMENT OF THE INITIAL DEVICE). THE DEVICE RELATIONSHIP AND DEVICE DEFICIENCY ASSESSMENT WERE THE SAME AS WITH THE PRIOR DEVICE." BARE MINIMUM: CDSM-8.5 MIGRATED AFTER 24 HOURS. THE DEVICE WAS REPLACED WITH CDSG-14-175 WHICH MIGRATED WITHIN 48 HOURS. TREATMENT IN BOTH CASES WAS REPLACEMENT OF THE DEVICE. THE TREATMENT WITH THE COLON DECOMPRESSION SET WAS CONSIDERED NOT SUCCESSFUL, WHEN THE 3RD DEVICE WAS REMOVED. NO ADVERSE EVENTS WERE REPORTED PRIOR TO THE PATIENT BEING EXITED FROM THE STUDY. 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2549390 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 Unknown