BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DUETTE MULTI-BAND MUCOSECTOMY DEVICE

    MDR report key: 17994218 · Received October 24, 2023

    Report

    Report Number
    3001845648-2023-00797
    Event Type
    Injury
    Date Received
    October 24, 2023
    Report Date
    March 12, 2024
    Manufacturer
    COOK IRELAND LTD
    Product Code
    KNS
    PMA / PMN Number
    K050578
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PMA/510(K) # DEN180062. DEVICE EVALUATION: THE DEVICE EVALUATION COULD NOT BE COMPLETED AS THE DEVICE OR PHOTOGRAPHIC EVIDENCE OF THE DEVICE WAS NOT RETURNED FOR EVALUATION. THERE ARE TWO METHODS BY WHICH PMCF COMPLAINTS ARE RECEIVED; 1. INITIAL/ FINAL PMCF REPORT IN A PDF FORMAT - THIS IS EMAILED BY COOK RESEARCH TEAM. 2. RESEARCH TEAM CAN DIRECTLY ASK CUSTOMER SERVICE TO OPEN COMPLAINTS ON TRACKWISE FOR ANY ONGOING CLINICAL STUDIES - SO THEY OPEN THESE COMPLAINTS AS AND WHEN THEY COME ACROSS THE MALFUNCTION/ ADVERSE EVENTS. THE STUDIES USUALLY GO ON FOR MANY MONTHS OR EVEN YEARS. SO THE RESEARCH TEAM MIGHT NOT HAVE A REPORT DRAFTED IN THIS CASE, THEY WOULD JUST CALL IN CUSTOMER SERVICE TO LOG THESE COMPLAINTS PR 407717 FALLS UNDER TYPE 2 ABOVE. MANUFACTURING RECORDS: PRIOR TO DISTRIBUTION, ALL ECHO-PPG-I DEVICES ARE SUBJECTED TO A VISUAL INSPECTION AND FUNCTIONAL INSPECTION TO ENSURE DEVICE INTEGRITY. A REVIEW OF THE MANUFACTURING RECORDS FOR ECHO-PPG-I OF LOT NUMBER C2038813 DID NOT REVEAL ANY DISCREPANCIES THAT COULD HAVE CONTRIBUTED TO THIS COMPLAINT ISSUE. INSTRUCTIONS FOR USE AND/LABEL: AS PER THE INSTRUCTIONS FOR USE, IFU0131 DAMAGE TO BLOOD VESSELS IS A KNOWN ADVERSE EVENT WHICH INFORMS THE USER ABOUT THE POTENTIAL ADVERSE EVENTS "THOSE ASSOCIATED WITH AN ENDOSCOPIC ULTRASOUND PROCEDURE INCLUDE: ALLERGIC REACTION TO MEDICATION, ASPIRATION, CARDIAC ARRHYTHMIA OR ARREST, DEATH, FEVER, HYPOTENSION, INFECTION, PAIN/DISCOMFORT, PERFORATION, RESPIRATORY DEPRESSION OR ARREST¿. ¿THOSE ASSOCIATED WITH THE DEVICE INCLUDE: ARTERIOVENOUS FISTULA, CHOLANGITIS, DAMAGE TO BLOOD VESSELS, EMBOLISM, FEVER, HEMORRHAGE, HYPOTENSION, INFECTION, INFLAMMATION, NERVE DAMAGE, PAIN/DISCOMFORT, PERFORATION, PNEUMOPERITONEUM, SEPSIS, SEPTICEMIA/BACTEREMIA, THROMBOSIS, VESSEL OCCLUSION, VESSEL TRAUMA¿. IMAGE REVIEW: AN IMAGE WAS NOT RETURNED FOR EVALUATION. ROOT CAUSE ANALYSIS: A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED FROM THE AVAILABLE INFORMATION. HOWEVER, THERE WAS NO EVIDENCE OF A FAILURE REPORTED ASSOCIATED WITH THE ACTUAL DEVICE. LACERATION OF THE TUNICA INTIMA OF THE PORTAL VEIN CAN BE COVERED BY ¿DAMAGE TO BLOOD VESSELS¿ AS A KNOWN POTENTIAL ADVERSE EVENT. AS PER MEDICAL AFFAIRS A POTENTIAL ROOT CAUSE COULD BE ATTRIBUTED TO THE TIPS PROCEDURE WITH A CATHETER MIGHT HAVE LIKELY DAMAGED THE TUNICA INTIMA. ANOTHER POSSIBLE ROOT CAUSE COULD ALSO BE ATTRIBUTED THE DIFFICULT ANATOMY OF THE PATIENT'S VEINS AS PER INFORMATION DETAILED IN THE PATIENT/EVENT INFO ¿ NOTES SECTION. SUMMARY: COMPLAINT IS CONFIRMED BASED ON CUSTOMER AND/OR REP TESTIMONY. THE EVENT DID LEAD TO A SERIOUS DETERIORATION IN HEALTH THAT RESULTED IN IN-PATIENT OR PROLONGED HOSPITALIZATION. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR SIMILAR EVENTS.

    Additional Manufacturer Narrative · 0

    INVESTIGATION IS STILL PENDING, A FOLLOW UP MDR WILL BE SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS.

    Description of Event or Problem · 0

    SONPAL , 20111 ¿ DUAL DUETTE DISASTERS: AN UNCOMMON COMPLICATION IN 2 PATIENTS. THE SECOND PATIENT, A 59 YEAR OLD MALE, UNDERWENT D-EMR FOR A RESIDUAL CARCINOID TUMOR OF THE RECTUM CASE 2: THE SECOND PATIENT, A 59 YEAR OLD MALE, UNDERWENT D-EMR FOR A RESIDUAL CARCINOID TUMOR OF THE RECTUM DIAGNOSED AND RESECTED BY POLYPECTOMY 8 YEARS PREVIOUSLY. ONE HOUR POST PROCEDURE THE PATIENT DEVELOPED ABDOMINAL PAIN AND TACHYCARDIA, REPEAT FLEXIBLE SIGMOIDOSCOPY SHOWED A CLOT AT THE EMR SITE WITHOUT ACTIVE BLEEDING OR DEFECTS. FIVE CLIPS WERE PLACED TO SEAL THE MUCOSA HOWEVER POSTOPERATIVE CT SCAN SHOWED EXTRAVASATION OF CONTRAST AND MASSIVE FREE INTRAPERITONEAL AND MEDIASTINAL AIR. THE PATIENT SUBSEQUENTLY HAD LAPAROSCOPIC REPAIR OF THE DEFECT WITH TEMPORARY DIVERSION COLOSTOMY AND DID WELL. THIS COMPLAINT CAPTURES THE OFF LABEL USE, DEVICE NOT USED IN THE UPPER GI TRACT AND RELATED ADVERSE EVENTS OF PERFORATIONS AND THE PAIN AND TACHYCARDIA ASSOCIATED WITH THE PERFORATION. REQUIRED PROCEDURE WITHIN THE SAME OPERATING PROCEDURE TO TREAT THE PERFORATION. (B)(4). REQUIRED PROCEDURE WITHIN THE SAME OPERATING PROCEDURE TO TREAT THE PERFORATION. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1236977 DUETTE MULTI-BAND MUCOSECTOMY DEVICE KNS UNIT, ELECTROSURGICAL, ENDOSCOPIC KNS COOK IRELAND LTD UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Male Required Intervention