BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CERELINK ICP PROBE 1L M BOLT

    MDR report key: 18697902 · Received February 13, 2024

    Report

    Report Number
    3013886523-2024-00039
    Event Type
    Injury
    Date Received
    February 13, 2024
    Report Date
    July 18, 2024
    Manufacturer
    INTEGRA LIFESCIENCES MANSFIELD
    Product Code
    GWM
    PMA / PMN Number
    K173192
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    UPDATED FIELDS: D4, D9, G3, G6, H2, H3, H4, H6, H11. CERELINK SENSOR WAS RETURNED FOR EVALUATION: DHR - LOT 6896058 (SN (B)(6)), MET SPECIFICATIONS WHEN RELEASED. FAILURE ANALYSIS - THE ISSUE OF THE COMPLAINT HAS BEEN CONFIRMED: - CATHETER NYLON STRETCHED IN MULTIPLE AREAS. - CATHETER INTERNAL WIRES ARE BROKEN . - ICP EXPRESS READ ¿NO TRANSDUCER DETECTED¿. - NO TESTING POSSIBLE. ROOT CAUSE - BASED ON THE FAILURE ANALYSIS, THE ROOT CAUSE COULD BE DETERMINED AS A MISHANDLING OF THE CATHETER.

    Additional Manufacturer Narrative · 0

    AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFORMATION. UPON COMPLETION OF THE INVESTIGATION, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    UPDATED FIELDS: G3, G6, H2. CORRECTED FIELD: D9.

    Description of Event or Problem · 0

    1 OF 3 REPORTS. OTHER MFG REPORT NUMBERS:3013886523-2024-000403013886523-2024-00041A FACILITY REPORTED A CERELINK SENSOR (ID 826851) HAD VERY HIGH PRESSURE (300), AND THEN A FLAT LINE WAS SEEN FIVE HOURS AFTER PLACEMENT. THE SENSOR WAS REMOVED AND REPLACED. THE SECOND SENSOR WORKED FOR 11 HOURS, THEN SUDDENLY, FLAT LINE. IT WAS EXPLANTED AND MONITORING STOPPED.THE SENSORS WERE CONNECTED TO DIRECTLINK MODULE (ID 826828).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    805413 CERELINK ICP PROBE 1L M BOLT ICP MICRSOSENSORS - CERELINK GWM INTEGRA LIFESCIENCES MANSFIELD 6896058

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown DIRECTLINK ICP MODULE (ID 826828)