BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLON DECOMPRESSION SET

    MDR report key: 15751516 · Received November 8, 2022

    Report

    Report Number
    3001845648-2022-00756
    Event Type
    Malfunction
    Date Received
    November 8, 2022
    Report Date
    November 21, 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. 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: N/A. IMAGE REVIEW: N/A. DOCUMENT REVIEW INCLUDING IFU REVIEW: AS THE LOT NUMBER OF THE COMPLAINT DEVICE IS UNKNOWN, A REVIEW OF THE RELEVANT MANUFACTURING RECORDS CANNOT BE CONDUCTED. HOWEVER, PRIOR TO DISTRIBUTION CDSG-14-175 DEVICES ARE SUBJECTED TO A VISUAL INSPECTION AND FUNCTIONAL CHECKS TO ENSURE DEVICE INTEGRITY. THESE INSPECTIONS AND FUNCTIONAL CHECKS ARE OUTLINED IN INTERNAL PROCEDURES IN PLACE AT CIRL. THE INSTRUCTIONS FOR USE STATES THE FOLLOWING IN RELATION TO POTENTIAL ADVERSE EVENTS ASSOCIATED WITH USE OF THIS DEVICE: ¿THOSE ASSOCIATED WITH COLON DECOMPRESSION INCLUDE, BUT ARE NOT LIMITED TO: CLOGGING OF THE TUBE, DISLODGEMENT OF THE COLON DECOMPRESSION TUBE/WIRE GUIDE, FEVER AND DISCOMFORT, HAEMORRHAGE, HYPOTENSION, INFECTION, MIGRATION, PAIN, PERFORATION, SEPSIS ." IT SHOULD BE NOTED THAT THE DEVICE WAS USED OFF-LABEL, OUTSIDE ITS INTENDED USE STATED IN THE INSTRUCTIONS FOR USE "THIS DEVICE IS INTENDED FOR TREATMENT OF ACUTE NON-TOXIC MEGACOLON, PSEUDO-OBSTRUCTION (OGILVIE'S SYNDROME) AND COLONIC STRICTURES" AND ¿DO NOT USE THIS DEVICE FOR ANY PURPOSE OTHER THAN STATED INTENDED USE.¿ THERE IS EVIDENCE TO SUGGEST THE USER DID NOT FOLLOW THE IFU. AS PER INFORMATION REPORTED IN THE PATIENT/EVENT INFO - NOTES SECTION, THERE IS NO ADDITIONAL MANUFACTURER QUESTIONS TO BE REQUESTED AS PER DIRECTION FROM COOK RESEARCH INSTITUTE MANAGEMENT. ROOT CAUSE REVIEW: A DEFINITIVE ROOT CAUSE CAN BE ATTRIBUTED TO THE OFF-LABEL USE OF THE DEVICE, WHEN THE DEVICE IS OUTSIDE IT STATED INTENDED USE. IT WAS CONFIRMED THAT THAT THE USE OF CDSG DEVICE IN THE VOLVULUS IS OFF LABEL USE. THE MIGRATION THAT OCCURRED IS SECONDARY TO THE OFF-LABEL USE. SUMMARY: THE COMPLAINT IS CONFIRMED BASED ON CUSTOMER TESTIMONY. ACCORDING TO THE INFORMATION REPORTED, THE 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 SUCCESSFUL. NO OTHER ADVERSE EVENTS WERE REPORTED PRIOR TO THE PATIENT BEING EXITED FROM THE STUDY. 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 FOLLOW-UP REPORT IS BEING SUBMITTED DUE TO THE COMPLETION OF THE INVESTIGATION ON 21-NOV-2022.

    Description of Event or Problem · 0

    AS REPORTED TO CUSTOMER RELATIONS VIA CRI FORM "CDSG-14-175 MIGRATED AT 48 HOURS AFTER THE INITIAL PLACEMENT PROCEDURE. THE EVENT WAS REPORTED AS NOT RELATED TO THE COLON DECOMPRESSION SET AND 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 SUCCESSFUL. NO OTHER 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. 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 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
    2528593 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 82 YR Male