BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLON DECOMPRESSION SET

    MDR report key: 15751253 · Received November 8, 2022

    Report

    Report Number
    3001845648-2022-00752
    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
    MN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

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

    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. IMAGE REVIEW AN IMAGE WAS NOT RETURNED FOR EVALUATION. 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. 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.

    Description of Event or Problem · 0

    AS REPORTED TO CUSTOMER RELATIONS VIA CRI FORM "CDSG-14-175 CLOGGED AT 48 HOURS AFTER THE INITIAL PLACEMENT PROCEDURE. THE EVENT WAS REPORTED AS RELATED TO THE COLON DECOMPRESSION SET AND AS OCCURRING DUE TO A DEVICE DEFICIENCY. THE SITE NOTED, ¿TUBE COILED WITHIN RIGHT HEMIABDOMEN. THE EVENT WAS REPORTED AS NOT RELATED TO THE STUDY PROCEDURE." THERE WAS NO TREATMENT OF THE EVENT. THE DEVICE WAS REMOVED AT 48 HOURS AFTER INITIAL PLACEMENT PROCEDURE 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. FINAL PMCF REPORT RECEIVED ON 10-OCT-2022. IT WAS CONFIRMED BY MEDICAL AFFAIRS THAT THE USE OF CDSG DEVICE IN THE VOLVULUS IS OFF LABEL USE.

    Description of Event or Problem · 0

    SUPPLEMENTAL FOLLOW-UP REPORT IS BEING SUBMITTED DUE TO THE COMPLETION OF THE INVESTIGATION ON (B)(6) 2022.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2548381 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 48 YR Male