BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CVAC ASPIRATION SYSTEM

    MDR report key: 23200675 · Received October 2, 2025

    Report

    Report Number
    3014683069-2025-00024
    Event Type
    Injury
    Date Received
    October 2, 2025
    Date of Event
    September 4, 2025
    Report Date
    October 2, 2025
    Manufacturer
    CALYXO, INC.
    Product Code
    FED
    PMA / PMN Number
    K233472
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H6. HEALTH EFFECT - CLINICAL CODE: 4581 APPROPRIATE TERM / CODE NOT AVAILABLE FOR REPORTED ILEUS. H6. HEALTH EFFECT - IMPACT CODE: 4650 APPROPRIATE TERM / CODE NOT AVAILABLE FOR REPORTED TAMPONADE WITH URETERAL STENT PLACEMENT. THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER FOR INVESTIGATION. THE SPECIFIC LOT NUMBER OF THE DEVICE USED DURING THIS 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. BLEEDING COMPLICATIONS, INCLUDING HEMATOMA, HAVE BEEN REPORTED IN APPROXIMATELY 0.6% TO 1.5% OF URETEROSCOPY PROCEDURES.

    Description of Event or Problem · 0

    ON (B)(6) 2025, A FEMALE PATIENT WITH A HISTORY OF INFLAMMATORY BOWEL DISEASE, ANEMIA, TOTAL COLECTOMY, NEPHROLITHIASIS, AND NEPHROCALCINOSIS WITH CALYCEAL DIVERTICULUM AND EMBEDDED SUBMUCOSAL STONES UNDERWENT STEERABLE URETEROSCOPIC RENAL EVACUATION (SURE) WITH THE CVAC SYSTEM FOR TREATMENT OF A MULTIFOCAL STONE BURDEN OF APPROXIMATELY <2 CM. VISUALIZATION REMAINED CLEAR DURING THE CASE, AND IT WAS COMPLETED SUCCESSFULLY. WITHIN ONE WEEK OF THE PROCEDURE, THE PATIENT WAS ADMITTED TO THE HOSPITAL WITH A SIGNIFICANT ILEUS. HEMOGLOBIN LEVELS BEGAN TO DROP, AND COMPUTED TOMOGRAPHY (CT) IMAGING REVEALED A SUBCAPSULAR HEMATOMA. WITHIN 24 HOURS OF ADMISSION, THE PATIENT RECEIVED A BLOOD TRANSFUSION, AND TAMPONADE WITH URETERAL STENT PLACEMENT WAS PERFORMED. THE STENT WAS REMOVED TWO WEEKS LATER, AND THE PATIENT HAS SINCE MADE A FULL RECOVERY. THE TREATING PHYSICIAN WAS UNCERTAIN WHETHER THE EVENTS WERE DIRECTLY CAUSED BY USE OF THE CVAC SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2435175 CVAC ASPIRATION SYSTEM ENDOSCOPIC ACCESS OVERTUBE, GASTROENTEROLOGY-UROLOGY FED CALYXO, INC. CVC127020-1

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Female Hospitalization| R