BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERMCATH

    MDR report key: 12307872 · Received August 11, 2021

    Report

    Report Number
    3009211636-2021-00206
    Event Type
    Injury
    Date Received
    August 11, 2021
    Date of Event
    May 27, 2021
    Report Date
    August 11, 2021
    Manufacturer
    COVIDIEN MFG SOLUTIONS S.A.
    Product Code
    KNZ
    UDI-DI
    10884521009929
    PMA / PMN Number
    K840424
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER, BLUNT DISSECTION WAS DONE TO REMOVE THE CATHETER'S CUFF BUT IT WAS UNSUCCESSFUL AFTER MULTIPLE ATTEMPTS. THE CATHETER WAS SAID TO BE VERY FLOPPY AND DIFFICULT TO REMOVE. THE DISTAL END OF THE CATHETER WAS INADVERTENTLY SEVERED AND THE PROXIMAL END OF THE CATHETER WAS CLAMPED WITH A HEMOSTAT. IT WAS SAID THAT THE PATIENT WAS THEN TRANSFERRED TO THE INTERVENTIONAL RADIOLOGY LABORATORY AND THE PATIENT'S NECK AND CHEST WAS THEN RE-PREPPED IN STERILE FASHION. FLUOROSCOPIC IMAGING REVEALED A SHEARED THOUGH INTACT TUNNELED DIALYSIS CATHETER. NEXT, SMALL INCISION WAS MADE SUPERIOR TO THE INSERTION SITE AND BY USING A 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 INTERVENTIONAL RADIOLOGY LABORATORY IN STABLE CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1202777 PERMCATH ACCESSORIES, A-V SHUNT KNZ COVIDIEN MFG SOLUTIONS S.A. 8888169001 10884521009929

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention