BEUDAMED
    FDA Adverse Event Death Summary report: N

    CODMAN BACTISEAL CATHETER KIT

    MDR report key: 13542170 · Received February 16, 2022

    Report

    Report Number
    3013886523-2022-00049
    Event Type
    Death
    Date Received
    February 16, 2022
    Date of Event
    January 14, 2022
    Report Date
    April 12, 2022
    Manufacturer
    INTEGRA LIFESCIENCES SWITZERLAND SAR
    Product Code
    JXG
    UDI-DI
    10381780515616
    PMA / PMN Number
    K102589
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    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 BACTISEAL CATHETER KIT (ID 823072) AS NOT RETURNED FOR EVALUATION AS THE PRODUCT IS NOT AVAILABLE FOR RETURN AS PER CUSTOMER; THEREFORE, AN EVALUATION OF THE DEVICE COULD NOT BE PERFORMED. LOT NUMBER INFORMATION HAS BEEN PROVIDED; THEREFORE, DEVICE HISTORY RECORD (DHR) WAS REVIEWED, AND NO ANOMALIES WERE FOUND. THE ROOT CAUSE(S) OF THE REPORTED ISSUE COULD NOT BE DETERMINED. 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. ACCORDING TO INTEGRA'S MEDICAL SAFETY ASSESSMENT: BASED ON THE COMPLAINT INFORMATION A CAUSAL RELATIONSHIP BET WEEN THE DEVICE AND THE DEMISE OF THE PATIENT IS INCONCLUSIVE WITHOUT INTERNAL INVESTIGATION OF THE DEVICE. IT APPEARS TO HAVE BEEN AN OVER DRAINAGE SCENARIO RESULTING FROM THE CHANGE OF THE CERTAS SETTINGS FROM 5 TO 4 WITHOUT RADIOGRAPHIC CONFIRMATION. THE ELECTRONIC PROGRAMMER WAS USED TO ADJUST AND VERIFY VALVE SETTINGS, AS IT IS CUSTOMARY PRACTICE THAT RADIOGRAPHS BE TAKEN TO CONFIRM THE PATIENT'S STATUS AND VALVE SETTINGS. AS STATED IN THE INSTRUCTIONS FOR USE (IFU), "ADJUSTING THE VALVE TO A PERFORMANCE SETTING THAT IS LOWER THAN NECESSARY CAN LEAD TO EXCESSIVE CSF DRAINAGE WHICH CAN CAUSE SUBDURAL HEMATOMAS".

    Description of Event or Problem · 0

    1 OF 2 REPORTS. SAME PATIENT, SAME EVENT, DIFFERENT PRODUCTS. OTHER MFG REPORT NUMBER: 3013886523-2022-00050. A FACILITY REPORTED A CERTAS PLUS VALVE (ID (B)(4)) WAS IMPLANTED WITH A BACTISEAL CATHETER (ID (B)(4)) VIA V-P SHUNT WITH SETTING AT 5 ON (B)(6) 2021, TO TREAT HYDROCEPHALUS. THE PATIENT IS A (B)(6) MALE WITH RELEVANT MEDICAL HISTORY OF CARDIAC COMORBIDITIES, PERIPHERAL VASCULAR DISEASE, ON ASPIRIN AND CLOPIDOGREL. TWO DAYS LATER, THE VALVE SETTING WAS CHANGED TO 4. NO X-RAY WAS TAKEN FOR CONFIRMATION AFTER THE SETTING CHANGE; HOWEVER, IT WAS CONFIRMED WITH THE ELECTRONIC PROGRAMMER AND CONFIRMED AGAIN IN THE CLINIC 2 WEEKS LATER. THE PATIENT DID NOT HAVE ANY MRI PROCEDURES AFTER THE SHUNT VALVE SYSTEM WAS IMPLANTED ON (B)(6) 2021. THE PATIENT DEVELOPED A SUBDURAL (BLOOD CLOT BETWEEN THE BRAIN AND DURA ON THE LEFT SIDE) ON THE OPPOSITE SIDE OF THE SHUNT AND ON (B)(6) 2022, THE PATIENT DIED. THE CAUSE OF DEATH WAS RULED AS ACUTE SUBDURAL BLEED ON THE LEFT SIDE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    4267 CODMAN BACTISEAL CATHETER KIT BACTISEAL CATHETER KIT JXG INTEGRA LIFESCIENCES SWITZERLAND SAR 823072 5471544 10381780515616

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Male Death