BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VENTRICULAR CATHETER ACCESSORY KIT (VCAK)

    MDR report key: 18428087 · Received January 2, 2024

    Report

    Report Number
    9612007-2023-00003
    Event Type
    Injury
    Date Received
    January 2, 2024
    Date of Event
    October 16, 2023
    Report Date
    February 22, 2024
    Manufacturer
    INTEGRA NEUROSCICENCS IMPLANTS SA
    Product Code
    JXG
    PMA / PMN Number
    K914995
    Report Source
    Manufacturer report
    Reporter Occupation
    PHARMACIST
    Health Professional
    Yes

    Narratives

    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

    THE VENTRICULAR CATHETER ACCESSORY KIT (951303) WAS NOT RETURNED FOR INVESTIGATION AND LOT NUMBER INFORMATION PROVIDED DOES NOT CORRESPOND TO AN INTEGRA PRODUCT; THEREFORE, DEVICE HISTORY RECORD (DHR) COULD NOT BE REVIEWED. FAILURE ANALYSIS - THE CUSTOMER REPORTED THAT THE CONNECTIVITY BETWEEN THE INTRACRANIAL TUBING AND EXTERNAL TUBING WAS DISCONNECTED/NOT CORRECTLY ADJUSTED EXPLAINING CSF LEAKAGE. THIS COULD BE DUE TO IMPROPER HANDLING OF THE DEVICE IN VIEW OF THE EVENT DESCRIPTION: "THE PATIENT MADE A COUGHING EFFORT LEADING TO A SOUND LIKE LEAKAGE AT THE EXTERNAL VENTRICULAR DERIVATION. THE OCCLUSIVE DRESSING OF EVD WAS CSF STAINED, THE PROTECTION SQUARE BEHIND THE HEAD OF THE PATIENT WAS ALSO SOAKED WITH CSF." IN ADDITION, THE BATCH NUMBER REPORTED IS INCORRECT AND IT IS NO LONGER POSSIBLE TO RETRIEVE THE CORRECT LOT NUMBER SINCE THE DEVICE WAS NOT KEPT. AS A RESULT, INSUFFICIENT EVIDENCE EXISTS TO CONFIRM OR SUGGEST A CASUAL RELATIONSHIP TO THE DEVICE. IF ADDITIONAL RELEVANT INFORMATION BECOMES AVAILABLE IN THE FUTURE, THIS COMPLAINT WILL BE REOPENED, AND THE RESPECTIVE EVALUATION PERFORMED. TRENDS WILL BE MONITORED FOR THIS AND SIMILAR ISSUES. AT PRESENT, WE CONSIDER THIS COMPLAINT TO BE CLOSED.

    Description of Event or Problem · 0

    A FACILITY REPORTED THAT THE VENTRICULAR CATHETER ACCESSORY KIT (951303) WAS USED ON A PATIENT, AND AT THE BEGINNING OF NURSING/CARE ON OCTOBER 16TH AT AROUND 4PM, THE PATIENT MADE A COUGHING EFFORT LEADING TO A SOUND LIKE LEAKAGE AT THE EXTERNAL VENTRICULAR DERIVATION. THE OCCLUSIVE DRESSING OF THE EVD WAS STAINED WITH CEREBROSPINAL FLUID (CSF), AND THE PROTECTION SQUARE BEHIND THE HEAD OF THE PATIENT WAS ALSO SOAKED WITH CSF. THE CONNECTIVITY BETWEEN THE INTRACRANIAL TUBING AND EXTERNAL TUBING WAS DISCONNECTED/NOT CORRECTLY ADJUSTED EXPLAINING THE CSF LEAKAGE, WHICH IS AN INFECTIOUS RISK. THE MEDICAL TEAM AND NEUROSURGEONS HAD TO BE CALLED, AND NEW CONNECTIVITY/CONNECTOR (PRESENT IN THE INTRACRANIAL CATHETER, ONLY THE CONNECTION AND NOT THE INTRACEREBRAL DEVICE) AND NEW EXTERNAL RECEIPT KIT WERE CHANGED. THE CHANGE WAS DONE IN STERILE ROOM BY THE MEDICAL TEAM. NO FURTHER INFORMATION IS AVAILABLE.

    Description of Event or Problem · 0

    N/A.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1409327 VENTRICULAR CATHETER ACCESSORY KIT (VCAK) EXTERNAL DRAINAGE ACCESSORIES JXG INTEGRA NEUROSCICENCS IMPLANTS SA 6987173

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Male