BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MICROSENSOR VENTRICULAR CATHETER KIT

    MDR report key: 2161935 · Received July 11, 2011

    Report

    Report Number
    1226348-2011-00258
    Event Type
    Injury
    Date Received
    July 11, 2011
    Date of Event
    June 13, 2011
    Manufacturer
    CODMAN & SHURTLEFF, INC.
    Product Code
    GWM
    PMA / PMN Number
    K991222
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: UPON COMPLETION OF THE INVESTIGATION IT WAS NOTED THAT THE SUPPLY PERFORMED THIS EVALUATION. DURING THE EVALUATION A REVIEW OF THE 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: THE CATHETER IS MOUNTED IN A DRAINAGE TUBE. THE CATHETER HAS BEEN STRETCHED BROKEN AT THE CODMAN WYE. THE WIRES ARE EXPOSED WRAPPED AROUND THE CONNECTOR. THE PRESSURE SENSOR IS FUNCTIONAL. THERE WAS DEBRIS OVER THE PRESSURE SENSOR. THERE IS TAPE WRAPPED AROUND THE CONNECTOR. DUE TO THE CONDITION OF THE CATHETER, THE SUPPLIER WAS UNABLE TO PERFORM TESTING. BASED ON THE ABOVE EVALUATION IT APPEARS THAT THE DEVICE WAS INADVERTENTLY DAMAGED/BROKEN BY THE CUSTOMER. NO FURTHER ACTION IS REQUIRED. TRENDS WILL BE MONITORED FOR THIS OR SIMILAR COMPLAINTS.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    AFFILIATE REPORTED THAT THE DEVICE WAS REVISED AS IT WAS NOTICED THAT THE SENSOR WAS BROKEN THREE DAYS AFTER IMPLANTATION. THE PATIENT IS SAID TO BE DOING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MICROSENSOR VENTRICULAR CATHETER KIT DEVICE, INTRACRANIAL PRESSURE MONITORING GWM CODMAN & SHURTLEFF, INC. NA 495291

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention