BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERMCATH CHRONIC SILICONE OVAL HEMODIALYSIS CATHETER

    MDR report key: 12130328 · Received July 6, 2021

    Report

    Report Number
    MW5102321
    Event Type
    Injury
    Date Received
    July 6, 2021
    Date of Event
    May 27, 2021
    Report Date
    July 1, 2021
    Manufacturer
    COVIDIEN LLC
    Product Code
    FIQ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    WI, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    BLUNT DISSECTION TO REMOVE CATHETER'S CUFF WAS UNSUCCESSFUL AFTER MULTIPLE ATTEMPTS. THE DISTAL END OF THE CATHETER WAS INADVERTENTLY SEVERED. THE PROXIMAL END OF THE CATHETER WAS CLAMPED WITH A HEMOSTAT. THE PATIENT WAS THEN TRANSFERRED TO THE INTERVENTIONAL RADIOLOGY LAB. THE PATIENT'S NECK AND CHEST THEN RE-PREPPED IN STERILE FASHION. FLUOROSCOPIC IMAGING REVEALED AN SHEARED THOUGH INTACT TUNNELED DIALYSIS CATHETER. NEXT, A SMALL INCISION WAS MADE SUPERIOR TO THE INSERTION SITE. USING SHARP AND BLUNT DISSECTION, THE CATHETER WAS FREED AND SUBSEQUENTLY REMOVED. MANUAL PRESSURE WAS HELD OVER THE RIGHT INTERNAL JUGULAR VEIN AREA UNTIL HEMOSTASIS WAS ACHIEVED. THE SMALL INCISION WAS CLOSED WITH 3-0 VICRYL SUTURE. THE PATIENT LEFT THE IR LAB IN STABLE CONDITION. CATHETER VERY FLOPPY AND DIFFICULT TO REMOVE. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1021037 PERMCATH CHRONIC SILICONE OVAL HEMODIALYSIS CATHETER CANNULA, A-V SHUNT FIQ COVIDIEN LLC UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention