BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BALLOON BIPOLAR TEMPORARY PACING ELECTRODE CATHETER, RIGHT HEART CURVE

    MDR report key: 25234664 · Received May 20, 2026

    Report

    Report Number
    1018233-2026-03279
    Event Type
    Malfunction
    Date Received
    May 20, 2026
    Date of Event
    May 1, 2026
    Report Date
    May 18, 2026
    Manufacturer
    C.R. BARD INC. (COVINGTON) -1018233
    Product Code
    LDF
    UDI-DI
    00801741011535
    PMA / PMN Number
    K800298
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION IS STILL IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED. UDI FORMAT UPDATED WITH AVAILABLE PRODUCT INFORMATION PER GUDID. H11: SECTION A THROUGH F - THE INFORMATION PROVIDED BY BD REPRESENTS ALL THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BD.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE TEMPORARY PACING ELECTRODE CATHETER HAS A HAIR INSIDE THE PACKAGING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    37543 BALLOON BIPOLAR TEMPORARY PACING ELECTRODE CATHETER, RIGHT HEART CURVE TEMPORARY PACING ELECTRODE CATHETER LDF C.R. BARD INC. (COVINGTON) -1018233 GFKX0175 00801741011535

    Patients

    Seq Age Sex Outcome Treatment
    1