BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CVAC ASPIRATION SYSTEM

    MDR report key: 23606359 · Received November 20, 2025

    Report

    Report Number
    3014683069-2025-00027
    Event Type
    Malfunction
    Date Received
    November 20, 2025
    Date of Event
    November 3, 2025
    Report Date
    December 12, 2025
    Manufacturer
    CALYXO INC.
    Product Code
    FED
    PMA / PMN Number
    K233472
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, 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 LOT HISTORY REVIEW (LHR) FOR LOT # 84881870 WAS CONDUCTED, WHICH CONFIRMED THAT THERE WERE NO NON-CONFORMANCES DURING THE MANUFACTURING PROCESS THAT COULD BE RELATED TO THE REPORTED EVENT. THE REVIEW INDICATED THAT THE DEVICE MET ALL DESIGN AND MANUFACTURING SPECIFICATIONS WHEN RELEASED FOR DISTRIBUTION. CALYXO IS REPORTING THIS EVENT OUT OF AN ABUNDANCE OF CAUTION.

    Additional Manufacturer Narrative · 0

    THE MANUFACTURER'S INVESTIGATION IS STILL UNDER PROGRESS.

    Description of Event or Problem · 0

    ON (B)(6) 2025, A PATIENT WITH A SUSPECTED RETROCAVAL URETER SUCCESSFULLY UNDERWENT A SURE PROCEDURE FOR A 15 MM LOWER POLE STONE. THE ANATOMY REQUIRED SUBSTANTIAL DEVICE DEFLECTION TO ACCESS THE KIDNEY. THE PHYSICIAN NOTED LOWER THAN EXPECTED DISTENSION IN THE URINARY TRACT. AT COMPLETION, RESISTANCE WAS NOTED DURING DEVICE WITHDRAWAL, AND THE DEVICE WAS REMOVED TOGETHER WITH THE URETERAL ACCESS SHEATH. VISUAL INSPECTION REVEALED A TEAR OF THE OUTER JACKET AT THE DISTAL END OF THE DEVICE. THERE WERE NO REPORTED CLINICAL CONSEQUENCES.THE TEAR MAY HAVE OCCURRED DUE TO EXCESSIVE MANIPULATION FORCES AND MECHANICAL STRAIN DUE TO THE PATIENT ANATOMY CAUSING THE RESISTANCE DURING DEVICE WITHDRAWAL. THE PRODUCT WAS DISCARDED AND IS UNAVAILABLE FOR EVALUATION. CALYXO IS REPORTING THIS EVENT DUE TO ABUNDANCE OF CAUTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2468369 CVAC ASPIRATION SYSTEM ENDOSCOPIC ACCESS OVERTUBE, GASTROENTEROLOGY-UROLOGY FED CALYXO INC. CVC127020-1 84881870

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown BOSTON SCIENTIFIC NAVIGATOR 13/15 FR UAS