BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICROSENSOR VENTRICULAR CATHETER KIT

    MDR report key: 1230649 · Received November 6, 2008

    Report

    Report Number
    1226348-2008-00301
    Event Type
    Malfunction
    Date Received
    November 6, 2008
    Manufacturer
    CODMAN & SHURTLEFF, INC.
    Product Code
    GWM
    PMA / PMN Number
    K991222
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    UPON COMPLETION OF THIS INVESTIGATION, IT WAS NOTED THAT THIS COMPLAINT HAVE BEEN CONFIRMED. THE SUPPLIER PERFORMED THIS EVAL AND DURING EVAL A REVIEW OF THE QUAL RECORDS WAS CONDUCTED AND PRIOR TO DISTRIBUTION THIS DEVICE MET ALL MFG AND QUALITY TESTING/INSPECTION SPECIFICATIONS. THE CATHETER WAS ALSO EVALUATED AND THE FOLLOWING OBSERVATIONS NOTED: THE PRESSURE SENSOR WAS INTACT BUT NOT FUNCTIONAL. SUTURE ATTACHED TO DRAINAGE TUBE 15 CM FROM TIP. INTERNAL CATHETER WIRES WERE STRETCHED AND BROKEN 28 CM FROM THE TIP. NO TESTING WAS POSSIBLE. BASED ON THE ABOVE EVAL IT APPEARS THAT IMPROPER USE HAS CAUSED THE DIFFICULTY REPORTED BY THE CUSTOMER. BASED ON THE RESULTS OF THIS INVESTIGATION NO FURTHER ACTION IS REQUIRED. TRENDS WILL BE MONITORED FOR THIS OR SIMILAR COMPLAINTS. AT THE PRESENT TIME THIS COMPLAINT IS CLOSED.

    Description of Event or Problem · 1

    REP REPORTED TRANSDUCER NOT GETTING READING. PT EXPIRED DUE TO EVENTS OTHER THAN THAT OF THE DEVICE. ADDITIONALLY, THERE IS NO INFO TO INDICATE THE DEVICE CAUSED OR CONTRIBUTED TO THE EXPIRATION OF THE PT.

    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 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR