BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MICROSENSOR VENTRICULAR CATHETER KIT

    MDR report key: 4220696 · Received November 3, 2014

    Report

    Report Number
    1226348-2014-12075
    Event Type
    Injury
    Date Received
    November 3, 2014
    Date of Event
    October 10, 2014
    Manufacturer
    CODMAN & SHURTLEFF, INC
    Product Code
    GWM
    PMA / PMN Number
    PK991222
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). UPON COMPLETION OF THE INVESTIGATION, A FOLLOW UP REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 1

    UPON COMPLETION OF THE INVESTIGATION IT WAS NOTED THAT AN EVALUATION WAS PERFORMED BY THE SUPPLIER. THE EVALUATION FOUND: A REVIEW OF QUALITY RECORDS WAS CONDUCTED AND PRIOR TO DISTRIBUTION THIS DEVICE MET ALL MANUFACTURING AND QUALITY TESTING/INSPECTION SPECIFICATIONS. THE CATHETER WAS EVALUATED AND THE FOLLOWING OBSERVATIONS NOTED: RECEIVED CATHETER IN A DRAINAGE TUBE. SENSOR NOT FUNCTIONAL. INTERNAL CATHETER WIRES ARE BROKEN NO TESTING WAS POSSIBLE. MANUFACTURING DATE: 8/26/2013. BASED ON THE ABOVE EVALUATION, THE SUPPLIER WAS ABLE TO CONFIRM THE COMPLAINT AND DETERMINED THAT THE FAILURE WAS RELATED TO MISHANDLING OF THE CATHETER. TRENDS WILL BE MONITORED FOR THIS OR SIMILAR COMPLAINTS. AT THE PRESENT TIME THIS COMPLAINT IS CLOSED.

    Additional Manufacturer Narrative · 1

    UPON COMPLETION OF THE INVESTIGATION A FOLLOW UP REPORT WILL BE FILED.

    Description of Event or Problem · 1

    THE AFFILIATE REPORTED: AFTER THE SENSOR WAS INSERTED INTO THE ICP, NO SIGNAL COULD BE DETECTED ON THE SCREEN. THE SURGEON REMOVED THE IMPLANTED SENSOR QUICKLY AND CHANGED ANOTHER ONE TO COMPLETE. (DURING USE ON PATIENT) WHAT ACTION WAS TAKEN/REQUIRED TO MANAGE THE PROBLEM DURING THE PROCEDURE? WITH SAME LIKE PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    700925 MICROSENSOR VENTRICULAR CATHETER KIT DEVICE, INTRACRANIAL PRESSURE MONITORING GWM CODMAN & SHURTLEFF, INC 439245

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention