BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PHOENIX CRX DIAMOND VALVE

    MDR report key: 260632 · Received January 31, 2000

    Report

    Report Number
    MW1018029
    Event Type
    Injury
    Date Received
    January 31, 2000
    Date of Event
    January 2, 2000
    Report Date
    January 28, 2000
    Manufacturer
    PHOENIX BIOMEDICAL CORP.
    Product Code
    JXG
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    WA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PT WITH PILOCYSTIC ASTROCYTOMA STATUS POST-RESECTION HAD MULTIPLE CSF PROXIMAL SHUNT FAILURES PRIOR TO THE PHOENIX DEVICE. THE PHOENIX VALVE AND A NEW PROXIMAL CATHETER WERE IMPLANTED. THE NEXT DAY THE VENTRICLES CONTINUED TO BE DILATED CONSISTENT WITH VALVULAR DYSFUNCTION. THE PT WAS RETURNED TO SURGERY WHERE THE DISTAL CATHETER WAS REMOVED FROM THE VALVE AND A VERY LOW FLOW WAS NOTED. THE VALVE WAS REMOVED FROM THE PROXIMAL CATHETER AND THE FLOW WAS ROBUST. THE VALVE WAS REPLACED. THE SHUNT THEN PUMPED AND REFILLED WELL WITH A BRISK FLOW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PHOENIX CRX DIAMOND VALVE CSF SHUNT VALVE JXG PHOENIX BIOMEDICAL CORP. DCV220A PP-0113

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR Required Intervention TYPE 15CM MODEL# SC01E.| PHOENIX ANTIBLOCK VENTRICULAR CATHETER - STRAIGHT