BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BACTISEAL BARIUM STRIPED CATH

    MDR report key: 20369155 · Received October 4, 2024

    Report

    Report Number
    3013886523-2024-00314
    Event Type
    Injury
    Date Received
    October 4, 2024
    Date of Event
    August 9, 2024
    Report Date
    December 17, 2024
    Manufacturer
    INTEGRA LIFESCIENCES MANSFIELD
    Product Code
    JXG
    PMA / PMN Number
    K031123
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN
    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 BACTISEAL BARIUM CATHETER (ID NS0340) WAS NOT RETURNED FOR EVALUATION AND LOT NUMBER INFORMATION HAS NOT BEEN PROVIDED; THEREFORE, AN EVALUATION OF THE DEVICE COULD NOT BE PERFORMED, AND DEVICE HISTORY RECORD (DHR) COULD NOT BE REVIEWED, HOWEVER, THE PROBABLE ROOT CAUSE FOR THE REPORTED COMPLAINT COULD BE DUE TO BIOLOGICAL DEBRIS AND PROTEIN BUILD UP INTERFERING WITH THE DEVICE. 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.

    Description of Event or Problem · 0

    A PHYSICIAN REPORTED A CERTAS VALVE WAS IMPLANTED WITH A BACTISEAL BARIUM CATHETER (ID (B)(6)) DUE TO UNKNOWN REASON VIA VENTRICULOPERITONEAL (VP) SHUNT ON UNKNOWN DATE WITH UNKNOWN SETTING. THE INITIAL PRESSURE SETTING WAS 3 BUT IT WAS CHANGED TO 5. THE SETTING WAS CHANGED BACK TO 3; HOWEVER, IT WAS EXPLANTED DUE TO ITS DYSFUNCTION. A T2 HASTE MAGNETIC RESONANCE IMAGING (MRI) (1.5T) WAS PERFORMED. INITIALLY, THERE WAS A SUSPICION OF ELECTRONIC TOOL KIT (ETK) MALFUNCTION, BUT IT WORKED PROPERLY. THE SYSTEM WAS EXPLANTED AND REPLACED WITH A NEW DEVICE ON UNKNOWN DATE.

    Description of Event or Problem · 0

    N/A.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1403831 BACTISEAL BARIUM STRIPED CATH BACTISEAL CATHETER KIT JXG INTEGRA LIFESCIENCES MANSFIELD

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention CERTAS PLUS VALVE (ID 828814)