BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERITONEAL CATHETER

    MDR report key: 10808567 · Received November 9, 2020

    Report

    Report Number
    3009211636-2020-00276
    Event Type
    Injury
    Date Received
    November 9, 2020
    Date of Event
    December 20, 2015
    Report Date
    November 9, 2020
    Manufacturer
    COVIDIEN MFG SOLUTIONS S.A.
    Product Code
    FJS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    TITLE: TENCKHOFF TUNNELED PERITONEAL CATHETER PLACEMENT IN THE PALLIATIVE TREATMENT OF MALIGNANT ASCITES: TECHNICAL RESULTS AND OVERALL CLINICAL OUTCOME. SOURCE: RADIOLOGY AND ONCOLOGY 2016; 50(2): 197-203. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    ACCORDING TO THE LITERATURE SOURCE OF STUDY PERFORMED IN 94 PATIENTS (27 MEN; 28.7% AND 67 WOMEN; 71.3%) BETWEEN MARCH 2006 AND JANUARY 2013 THAT ANALYZED THE TECHNICAL FEASIBILITY AND SAFETY OF THE INSERTION OF A PERITONEAL TUNNELLED CATHETER. THE OVERALL CLINICAL OUTCOMES IN THIS PATIENT POPULATION WERE ANALYSED AND THE AUTHORS EVALUATED THE FEASIBILITY AND SAFETY OF INTRAPERITONEAL CHEMOTHERAPY DELIVERY THROUGH THE PERITONEAL CATHETER IN PATIENTS WITH WIDESPREAD OVARIAN CANCER AND REFRACTORY ASCITES USING CATUMAXOMAB. ALL PATIENTS WERE SUCCESSFULLY INSERTED WITH TUNNELED PERITONEAL CATHETER; IN 90 PATIENTS, CATHETER WAS TUNNELED SUBCUTANEOUSLY INTO THE RIGHT FLANK, IN THE REMAINING 4 PATIENTS THE PERITONEAL ACCESS WAS MADE IN THE LEFT PARA AND INFRAUMBILICAL REGION AND THE CATHETER WAS TUNNELED IN THE LEFT FLANK. TWO PATIENTS (2.1%) PRESENTED WITH A CLINICAL SUSPICION OF CATHETER INFECTION, INCLUDING FEVER, PAINFUL CUTANEOUS AND SUBCUTANEOUS TUNNEL INFECTION, BUT WITHOUT CLEAR SIGNS OF PERITONITIS, 36 <(>&<)> 40 DAYS RESPECTIVELY AFTER INITIAL CATHETER PLACEMENT. THE USE OF THIS DEVICE TO ADMINISTER CHEMOTHERAPY IS NOT AN APPROVED INDICATION AND AS SUCH IS CONSIDERED OFF LABEL USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1275940 PERITONEAL CATHETER CATHETER, PERITONEAL, LONG-TERM INDWELLING FJS COVIDIEN MFG SOLUTIONS S.A. PERITONEAL CATHETER

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention