BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CERELINK ICP PROBE BASIC KIT

    MDR report key: 16807191 · Received April 25, 2023

    Report

    Report Number
    3013886523-2023-00122
    Event Type
    Injury
    Date Received
    April 25, 2023
    Date of Event
    April 5, 2023
    Report Date
    July 7, 2023
    Manufacturer
    INTEGRA LIFESCIENCES SWITZERLAND SAR
    Product Code
    GWM
    PMA / PMN Number
    K173192
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE MICROSENSOR (ID 826851) WAS RETURNED FOR EVALUATION. DEVICE HISTORY RECORD (DHR) - LOT 6202214, SN (B)(6) MET SPECIFICATIONS WHEN RELEASED. FAILURE ANALYSIS - THE ISSUE OF THE COMPLAINT HAS BEEN CONFIRMED: - CATHETER NICKED 14CM FROM SENSOR TIP EXPOSING INTERNAL WIRES; AND TAPE BUNCHED UP AROUND CATHETER - CATHETER COVERED IN GAUZE IN TAPE - CATHETER TWISTED INTO A LOOP IN THE MIDDLE OF CATHETER - CERELINK MONITOR READ ¿ACCEPTABLE¿; ICP EXPRESS = 520 - NO TESTING WAS POSSIBLE, DUE TO THE INTERNAL WIRES EXPOSED. THE POSSIBLE ROOT CAUSE FOR THIS ISSUE REPORTED BY THE CUSTOMER COULD BE DUE TO 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.

    Description of Event or Problem · 0

    THIS IS 1 OF 2 REPORTS LINKED TO MFG REPORT NUMBERS: 3013886523-2023-00123. A FACILITY REPORTED A MICROSENSOR (ID 826851-SERIAL (B)(6) WAS SHOWING NEGATIVE NUMBERS ON THE ICP EXPRESS MONITOR. THE FIRST MICROSENSOR WAS IMPLANTED ON (B)(6) 2023 AND SUDDENLY STARTED TO READ NUMBERS IN THE RANGE OF -8 TO -5. THEREFORE, THE MICROSENSOR WAS REMOVED ON (B)(6) 2023 AND WAS REPLACED WITH ANOTHER MICROSENSOR (ID 826851-SERIAL (B)(6). THE REPLACED MICROSENSOR DROPPED TO -8 AND WAS ALSO REMOVED. THE TIMEFRAME BETWEEN IMPLANTATION AND EXPLANTATION DATE WAS 24 HOURS EACH FOR BOTH SENSORS. THE PATIENT RECOVERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1188314 CERELINK ICP PROBE BASIC KIT ICP MICRSOSENSORS - CERELINK GWM INTEGRA LIFESCIENCES SWITZERLAND SAR

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown ICP EXPRESS