BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CVAC ASPIRATION SYSTEM

    MDR report key: 23732902 · Received December 5, 2025

    Report

    Report Number
    3014683069-2025-00030
    Event Type
    Injury
    Date Received
    December 5, 2025
    Date of Event
    October 30, 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
    TN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS RETURNED FOR INVESTIGATION. BASED ON THE REPORTED EVENT AND THE INVESTIGATION RESULTS, THERE WERE NO INDICATIONS THAT THE DEVICE WOULD BE LIKELY TO CAUSE THE REPORTED ISSUE WITH THE URETER. MULTIPLE DEVICES WERE USED IN THE PROCEDURE INCLUDING DEVICES FROM OTHER MANUFACTURERS TO GAIN ACCESS TO THE KIDNEY AND THE DETAILS OF THE PATIENT'S ANATOMY ARE UNKNOWN. THERE WAS INSUFFICIENT INFORMATION TO ASCERTAIN THE POSSIBILITY THAT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE URETERAL PERFORATION RESULTING IN STENT PLACEMENT. URETERAL PERFORATIONS 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). A STENT PLACEMENT IS SOMETIMES REQUIRED TO FACILITATE HEALING. POST-PROCEDURAL STENT PLACEMENT IS ALSO COMMON PRACTICE, EVEN IN THE ABSENCE OF A URETERAL INJURY. PER COMMUNICATION WITH FDA ON 11-NOV-2025, CALYXO IS REPORTING THE EVENT IN 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

    DURING A SURE PROCEDURE PERFORMED WITHOUT AN ACCESS SHEATH, THE PHYSICIAN NOTED A URETERAL PERFORATION, CONFIRMED BY CONTRAST EXTRAVASATION AND DIRECT VISUALIZATION. A STENT WAS PLACED, AND NO FURTHER INTERVENTION WAS ANTICIPATED. THE PATIENT WAS DISCHARGED IN STABLE CONDITION WITH MILD PAIN. 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
    2876850 CVAC ASPIRATION SYSTEM ENDOSCOPIC ACCESS OVERTUBE, GASTROENTEROLOGY-UROLOGY FED CALYXO INC. CVC127020-1 P02130

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention