BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HAKIM VENTRICULAR CATH

    MDR report key: 8637903 · Received May 23, 2019

    Report

    Report Number
    1226348-2019-00163
    Event Type
    Malfunction
    Date Received
    May 23, 2019
    Report Date
    May 7, 2019
    Manufacturer
    RAYNHAM
    Product Code
    JXG
    PMA / PMN Number
    K944222
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    UDI (B)(4). SAMPLE WAS RECEIVED FOR EVALUATION. FAILURE ANALYSIS: THE VALVE WAS VISUALLY INSPECTED; THE NEEDLE GUARD WAS RAISED. THE VALVE WAS FLUSHED AND OCCLUSION WAS NOTED DUE TO THE RAISED NEEDLE GUARD. THE NEEDLE CHAMBER WAS DISMANTLED. GLUE TRACES WERE NOTED ON THE NEEDLE CHAMBER BASE, THE NEEDLE GUARD WAS BENT. THE ROOT CAUSE FOR THE OCCLUSION IS DUE TO THE RAISED NEEDLE GUARD. THE ROOT CAUSE FOR THE RAISED NEEDLE GUARD DISC IS DUE TO HANDLING (AS NOTED IN THE IFU: DO NOT FOLD OR BEND THE VALVE, FOLDING OR BENDING MIGHT CAUSE RUPTURE OF THE SILICONE HOUSING, NEEDLE GUARD DISC DISLODGEMENT OR OCCLUSION OF THE FLUID PATHWAY). NO LOT INFORMATION WAS PROVIDED THEREFORE NO MANUFACTURING RECORDS COULD BE REVIEWED. BASED ON THE RESULTS OF THE INVESTIGATION, THE REPORTED ISSUE IS CONFIRMED. TRENDS WILL BE MONITORED FOR THIS AND SIMILAR ISSUES. AT PRESENT, WE CONSIDER THIS COMPLAINT TO BE CLOSED.

    Description of Event or Problem · 0

    ON (B)(6) 2019, A REVISION SURGERY WAS PERFORMED UNDER GENERAL ANESTHESIA. THE HAKIM CATHETER STYLET (82-3041) AND THE HAKIM VALVE WERE REMOVED FROM THE PATIENT BODY. THE ABDOMINAL CATHETER (82-3045) WAS REMOVED FROM THE PATIENT¿S BODY DURING THE SURGERY, AND IT WAS IMPLANTED AGAIN. THE OBSTRUCTION OF THE ABDOMINAL CATHETER WAS SUSPECTED. PATIENT IS RECOVERING WELL.

    Description of Event or Problem · 0

    N/A.

    Additional Manufacturer Narrative · 1

    THE DEVICE INVOLVED IN THE REPORTED INCIDENT IS NOT AVAILABLE FOR EVALUATION. AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ONE MONTH AFTER VALVE IMPLANTATION ITS VENTRICULAR CATHETER SIDE IS OBSTRUCTED. IT WAS CONFIRMED IN THE MIDDLE OF (B)(6) 2019. THEREFORE THE CATHETER WILL BE REMOVED AND EXCHANGED TO A NEW CATHETER WHEN THE PATIENT¿S CONDITION IS STABLE. THE CONCOMITANT VALVE IS 82-8804, AND THE DISTAL CATHETER IS 82-3045. NO FURTHER INFORMATION WAS PROVIDED BY THE HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    430381 HAKIM VENTRICULAR CATH STANDARD CATHETERS JXG RAYNHAM

    Patients

    Seq Age Sex Outcome Treatment
    1