BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CVAC ASPIRATION SYSTEM

    MDR report key: 23733814 · Received December 5, 2025

    Report

    Report Number
    3014683069-2025-00033
    Event Type
    Injury
    Date Received
    December 5, 2025
    Date of Event
    November 15, 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
    VA, 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). 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 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 PHYSICIAN NOTED THE PATIENT HAD A HIGHER AND NARROWER URETEROPELVIC JUNCTION (UPJ) THAN USUAL. DURING THE PROCEDURE, THE PHYSICIAN NOTICED A TEAR AT THE UPJ WHEN HE PULLED THE DEVICE BACK TOWARDS WHERE THE URETERAL ACCESS SHEATH WAS PLACED. THE PATIENT WAS FITTED WITH A ROUTINE URETERAL STENT FOR 4 WEEKS AND THE PROCEDURE WAS COMPLETED. THE PATIENT'S CONDITION WAS REPORTED AS STABLE POST THE 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
    1991223 CVAC ASPIRATION SYSTEM ENDOSCOPIC ACCESS OVERTUBE, GASTROENTEROLOGY-UROLOGY FED CALYXO INC. CVC127020-1

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other