BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CERELINK ICP PROBE 1L M BOLT

    MDR report key: 16732122 · Received April 13, 2023

    Report

    Report Number
    3013886523-2023-00107
    Event Type
    Injury
    Date Received
    April 13, 2023
    Date of Event
    March 26, 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 CERELINK SENSOR (ID 826851) WAS RETURNED FOR EVALUATION. DEVICE HISTORY RECORD (DHR) - THE PRODUCT 826851 FOR LOT 5842794 (SN (B)(6), AND THE LOT MET SPECIFICATIONS WHEN RELEASED. FAILURE ANALYSIS - THE ISSUE OF THE COMPLAINT HAS BEEN CONFIRMED: CATHETER STRETCHED 34 AND 51 CM FROM CONNECTOR; AND TAPE BUNCHED UP AROUND CATHETER. CERELINK MONITOR READ ¿NOT ACCEPTABLE¿; ICP EXPRESS AND NO TRANSDUCER DETECTED. INTERNAL WIRES BROKEN, NO TESTING WAS POSSIBLE. THE POSSIBLE ROOT CAUSE OF THE ISSUE REPORTED BY CUSTOMER COULD BE DETERMINED AS A MISHANDLING OF THE DEVICE 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

    N/A.

    Description of Event or Problem · 0

    A FACILITY REPORTED A CERELINK SENSOR (ID 826851) WAS IMPLANTED ON (B)(6) 2023. THE PATIENT WAS SHOWING ICP OF 3MMHG WITH PROPER WAVEFORM FOR APPROXIMATELY 2 HOURS, BUT THEN HAD READING OF ~350MMHG AND YELLOW LIGHT WAS DISPLAYED ON DIRECTLINK ICP MODULE. YELLOW LIGHT WOULD NOT BEGIN TO BLINK AND TURN GREEN TO CONFIRM PROPER FUNCTIONING OF SYSTEM. ALL CORDS WERE DISCONNECTED AND RECONNECTED. PROPER CALIBRATION AND RECONNECTION PROCESS WAS PERFORMED, BUT ISSUE PERSISTED. UPON FURTHER INSPECTION IT WAS DISCOVERED THAT SENSOR HAD ¿THINNER¿ PARTS TO IT THAT OTHERS. ANOTHER PROBE WAS BROUGHT IT AND IT WAS FOUND THAT IMPLANTED SENSOR WAS APPROXIMATELY 6CM LONGER THAN IN-TACT SENSOR. IT IS BELIEVED THAT SENSOR WAS STRETCHED OUT AND CONNECTION IN SENSOR WAS SEVERED. THE SENSOR WAS EXPLANTED ON (B)(6) 2023.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1027291 CERELINK ICP PROBE 1L M BOLT ICP MICRSOSENSORS - CERELINK GWM INTEGRA LIFESCIENCES SWITZERLAND SAR

    Patients

    Seq Age Sex Outcome Treatment
    1 Male DIRECTLINK EXTENSION CABLE.| DIRECTLINK ICP MODULE.| PHILLIPS BEDSIDE MONITOR CABLE.