BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTRATHECAL CATHETER

    MDR report key: 15880662 · Received November 29, 2022

    Report

    Report Number
    3010079947-2022-00210
    Event Type
    Injury
    Date Received
    November 29, 2022
    Date of Event
    November 21, 2022
    Report Date
    November 21, 2022
    Manufacturer
    FLOWONIX MEDICAL, INC.
    Product Code
    LKK
    UDI-DI
    00810335020099
    PMA / PMN Number
    P080012
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A REVIEW OF THE DEVICE HISTORY RECORD, WHICH INCLUDES VERIFICATION OF ALL STEPS IN THE MANUFACTURING OF THE US CATHETER KIT, VERIFICATION OF ALL FINAL TESTING PERFORMED BY/ON THE US CATHETER KIT, AND PACKAGING FOR SUBJECT US CATHETER KIT WAS PERFORMED. THE REVIEW DID NOT IDENTIFY ANY NON-CONFORMANCES, ISSUES OR CAPAS ASSOCIATED WITH US CATHETER KIT FUNCTION. DEVICE WAS NOT RETURNED FOR ADDITIONAL EVALUATION AND INVESTIGATION. IT WAS REPORTED THAT THE PHYSICIAN DOES NOT KNOW WHY THE CATHETER SHEARED. PER THE INSTRUCTIONS FOR USE OF THE DEVICE, CATHETER TEARS AND BREAKS ARE KNOWN POSSIBLE RISKS OF USE OF THE DEVICE. INTERNAL COMPLAINT NUMBER: (B)(4).

    Description of Event or Problem · 0

    PATIENT TRACKING RECEIVED A CATHETER REVISION TRACKING FORM REPORTING A CATHETER REVISION DUE TO IT BEING "BROKEN". ADDITIONAL COMMUNICATION WITH THE REPRESENTATIVE COVERING THE ISSUE CONFIRMED THAT THE CATHETER WAS SHEARED AT THE ENTRY POINT IN THE PATIENT'S SPINE. THIS CATHETER DAMAGE WAS DIAGNOSED WITH A CAP PROCEDURE WHICH OBSERVED THAT DYE WAS POOLED OUTSIDE OF THE SPINE. IT WAS REPORTED THAT THE PATIENT ALLEGED A LACK OF EFFICACY OF THEIR THERAPY. DURING THE REVISION SURGERY, THE CATHETER WAS TIED OFF AND NOT REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2676727 INTRATHECAL CATHETER INTRATHECAL CATHETER LKK FLOWONIX MEDICAL, INC. 11823 26506 00810335020099

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention