BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CVAC ASPIRATION SYSTEM

    MDR report key: 23810371 · Received December 15, 2025

    Report

    Report Number
    3014683069-2025-00034
    Event Type
    Malfunction
    Date Received
    December 15, 2025
    Date of Event
    November 21, 2025
    Report Date
    December 15, 2025
    Manufacturer
    CALYXO INC.
    Product Code
    FED
    PMA / PMN Number
    K233472
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT ANALYSIS COULD NOT BE UNDERTAKEN AS THE DEVICE WAS NOT RETURNED FOR INVESTIGATION. THE SPECIFIC LOT NUMBER OF THE DEVICE USED DURING THE PROCEDURE IS UNKNOWN; HOWEVER, A LOT HISTORY REVIEW (LHR) OF ALL LOTS SHIPPED TO THE ACCOUNT WITHIN TWO MONTHS OF THE PROCEDURE WAS CONDUCTED. THE REVIEW CONFIRMED THAT THERE WERE NO NONCONFORMANCES DURING THE MANUFACTURING PROCESS THAT COULD BE RELATED TO THE REPORTED EVENT. THE REVIEW INDICATED THAT THE DEVICES IN THESE LOTS MET ALL DESIGN AND MANUFACTURING SPECIFICATIONS WHEN RELEASED FOR DISTRIBUTION. CALYXO IS REPORTING THIS EVENT IN AN ABUNDANCE OF CAUTION.

    Description of Event or Problem · 0

    DURING A SURE PROCEDURE ON (B)(6) 2025 WITH A 12/14 BOSTON SCIENTIFIC URETERAL ACCESS SHEATH (UAS), THE PHYSICIAN HAD TO NAVIGATE THROUGH A SHARP ANATOMICAL ANGLE TO TREAT A LOWER POLE KIDNEY STONE. FOLLOWING MANIPULATION OF THE DEVICE AT THIS SHARP ANGLE FOR A SIGNIFICANT DURATION, A TEAR WAS NOTED IN THE OUTER JACKET OF THE DEVICE RESULTING IN IT BECOMING LODGED WITHIN THE UAS DURING ATTEMPTED WITHDRAWAL THROUGH THE UAS. THE DEVICE AND THE UAS WERE WITHDRAWN TOGETHER. A REPLACEMENT DEVICE WAS USED TO COMPLETE THE PROCEDURE, AND NO ADVERSE EVENT WAS REPORTED. CALYXO IS REPORTING THIS EVENT IN AN ABUNDANCE OF CAUTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    290257 CVAC ASPIRATION SYSTEM ENDOSCOPIC ACCESS OVERTUBE, GASTROENTEROLOGY-UROLOGY FED CALYXO INC. CVC127020-1

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown BOSTON SCIENTIFIC UAS 12/14 FR