BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAXCORE

    MDR report key: 24625398 · Received March 18, 2026

    Report

    Report Number
    2020394-2026-00679
    Event Type
    Malfunction
    Date Received
    March 18, 2026
    Date of Event
    February 26, 2026
    Report Date
    February 27, 2026
    Manufacturer
    BARD PERIPHERAL VASCULAR, INC.
    Product Code
    KNW
    UDI-DI
    00801741084454
    PMA / PMN Number
    K133948
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H11: MANUFACTURING REVIEW: THE DEVICE HISTORY RECORDS HAVE BEEN REVIEWED, AND THIS LOT MET ALL RELEASE CRITERIA. INVESTIGATION SUMMARY: THE PHYSICAL DEVICE WAS NOT RETURNED FOR EVALUATION. TWO ELECTRONIC PHOTOS WERE PROVIDED AND REVIEWED. THE FIRST PHOTO SHOWS ONE MAXCORE DEVICE IN INITIAL POSITION AND HAS PROTECTIVE TUBING, YELLOW GUARD AND LABELLING INFORMATION IS SHOWN BESIDE THE MAXCORE DEVICE WHICH WAS CROSS VERIFIED WITH THE TRACK WISE DETAILS. THE SECOND PHOTO SHOWS ONE MAXCORE DEVICE IN INITIAL POSITION WITH PROTECTIVE TUBING AND LABELLING INFORMATION IS SHOWN BESIDE THE MAXCORE DEVICE WHICH WAS CROSS VERIFIED WITH THE TRACK WISE DETAILS. NO OTHER ANOMALIES WERE IDENTIFIED. BASED ON THE PHOTO REVIEW, THE REPORTED EVENT CANNOT BE CONFIRMED. THEREFORE, THE INVESTIGATION IS INCONCLUSIVE FOR THE REPORTED FAILURE AS THE PROVIDED PHOTO EVIDENCE DOES NOT SUPPORT THE EVENT. A DEFINITIVE ROOT CAUSE FOR THE REPORTED FAILURE TO FIRE ISSUE COULD NOT BE DETERMINED BASED UPON THE PROVIDED INFORMATION. IT IS UNKNOWN WHETHER PATIENT AND/OR PROCEDURAL ISSUES CONTRIBUTED TO THE REPORTED EVENT. LABELING REVIEW: AS THE REPORTED EVENT DID NOT ALLEGE A LABELING OR USE RELATED ISSUE, A LABELING REVIEW IS NOT REQUIRED. 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

    ON (B)(6) 2026, A PATIENT UNDERWENT AN ULTRASOUND GUIDE KIDNEY BIOPSY PROCEDURE VIA NORMAL DENSITY TISSUE BY USING THE MAXCORE INSTRUMENT. IT WAS REPORTED THAT DURING THE PROCEDURE, THE DEVICE OUTER CANNULA ALLEGEDLY FAILED TO FIRE. NO COAXIAL NEEDLE WAS USED. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    688146 MAXCORE BIOPSY INSTRUMENT KNW BARD PERIPHERAL VASCULAR, INC. REKV2878 00801741084454

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown