BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CVAC ASPIRATION SYSTEM

    MDR report key: 23733546 · Received December 5, 2025

    Report

    Report Number
    3014683069-2025-00032
    Event Type
    Injury
    Date Received
    December 5, 2025
    Date of Event
    November 4, 2024
    Report Date
    December 5, 2025
    Manufacturer
    CALYXO INC.
    Product Code
    FED
    PMA / PMN Number
    K233472
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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. LOT HISTORY REVIEW COULD NOT BE PERFORMED AS THE LOT NUMBER OF THE DEVICE IS UNKNOWN. HENCE A DEFINITIVE ROOT CAUSE FOR THE REPORTED ISSUE COULD NOT BE DETERMINED. URETERAL TEARS ARE A KNOWN COMPLICATION IN URETEROSCOPIC STONE REMOVAL PROCEDURES AND IS ALSO LISTED AS A POTENTIAL ADVERSE EVENT IN THE DEVICE INSTRUCTIONS FOR USE (IFU). THERE WAS INSUFFICIENT INFORMATION TO ASCERTAIN THE POSSIBILITY THAT THE CVAC MAY HAVE CAUSED OR CONTRIBUTED TO THE TEAR. PER COMMUNICATION WITH FDA ON 11-NOV-2025, CALYXO IS REPORTING THIS EVENT OUT OF AN ABUNDANCE OF CAUTION. THIS IS BEING SUBMITTED MORE THAN 30 DAYS AFTER THE AWARE DATE AS A RESULT OF THE REASSESSMENT PER COMMUNICATION WITH FDA.

    Description of Event or Problem · 0

    ON (B)(6) 2024, A PATIENT UNDERWENT A SUCCESSFUL STEERABLE URETEROSCOPIC RENAL EVACUATION (SURE) PROCEDURE. THE TREATING PHYSICIAN DID NOT USE A URETERAL ACCESS SHEATH DURING THE PROCEDURE. DURING THE PROCEDURE, A SMALL TEAR WAS NOTED AT AN UNSPECIFIED LOCATION IN ONE OF THE PATIENT'S URETERS. AT THE TIME WHEN THE TEAR WAS NOTED, IT WAS REPORTED THAT VISIBILITY HAD BECOME CHALLENGING AS THE SALINE MAY HAVE BEEN CLOSE TO BEING EMPTY. THE PATIENT WAS NOT STENTED AND DID NOT REQUIRE ANY ADDITIONAL INTERVENTION FOR THE REPORTED TEAR. THE PATIENT WAS REPORTED TO BE DOING WELL POST PROCEDURE. CALYXO IS REPORTING THE EVENT OUT OF AN ABUNDANCE OF CAUTION BASED ON A REASSESSMENT OF THIS EVENT PER COMMUNICATION WITH FDA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1990246 CVAC ASPIRATION SYSTEM ENDOSCOPIC ACCESS OVERTUBE, GASTROENTEROLOGY-UROLOGY FED CALYXO INC. CVC127020-1

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown