BEUDAMED
    FDA Adverse Event Death Summary report: N

    CROSSER RECANALIZATION CATHETER

    MDR report key: 3800143 · Received May 1, 2014

    Report

    Report Number
    2020394-2014-00201
    Event Type
    Death
    Date Received
    May 1, 2014
    Date of Event
    March 5, 2014
    Report Date
    April 4, 2014
    Manufacturer
    BARD PERIPHERAL VASCULAR, INC.
    Product Code
    PDU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE LOT NUMBER FOR THE DEVICE HAS BEEN PROVIDED. A REVIEW OF THE DEVICE HISTORY RECORDS IS CURRENTLY BEING PERFORMED. THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. THE INVESTIGATION IS CURRENTLY UNDERWAY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT 16 DAYS AFTER THE SUCCESSFUL RECANALIZATION OF THE LEFT PERONEAL AND ANTERIOR TIBIAL ARTERIES WITH THE RECANALIZATION CATHETER, THE PATIENT EXPIRED. THE DEVICE PERFORMED AS INTENDED DURING THE PROCEDURE AND THERE WAS NO REPORTED PATIENT INJURY. THE PATIENT RECOVERED AND DIALYSIS WAS SUBSEQUENTLY PERFORMED WITHOUT INCIDENT. THE PHYSICIAN STATED THAT THERE WAS NO RELATIONSHIP OF THE RECANALIZATION CATHETER TO THE PATIENT'S DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    261960 CROSSER RECANALIZATION CATHETER RECANALIZATION CATHETER PDU BARD PERIPHERAL VASCULAR, INC. GFXJ0877

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Death