BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CVAC ASPIRATION SYSTEM

    MDR report key: 25190821 · Received May 15, 2026

    Report

    Report Number
    3014683069-2026-00018
    Event Type
    Injury
    Date Received
    May 15, 2026
    Date of Event
    April 15, 2026
    Report Date
    May 12, 2026
    Manufacturer
    CALYXO, INC.
    Product Code
    FED
    PMA / PMN Number
    K233472
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS NOT RETURNED FOR EVALUATION, THEREFORE, PRODUCT ANALYSIS COULD NOT BE PERFORMED. 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 NONCONFORMANCE'S 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. URETERAL INJURIES 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. CALYXO WILL CONTINUE TO PERFORM PRODUCT MONITORING AS PART OF OUR POST-MARKET SURVEILLANCE PROCEDURES.

    Description of Event or Problem · 0

    ON (B)(6) 2026, A PATIENT UNDERWENT A STEERABLE URETEROSCOPIC RENAL EVACUATION (SURE) PROCEDURE. RESISTANCE WAS ENCOUNTERED WHILE ATTEMPTING TO ADVANCE THE URETERAL ACCESS SHEATH THROUGH THE URETER. THE USER ELECTED TO PROCEED BY ADVANCING THE DEVICE WITHOUT USE OF THE SHEATH. A URETERAL MUCOSAL INJURY WAS IDENTIFIED AND THE PROCEDURE WAS DISCONTINUED. A URETERAL STENT WAS PLACED FOR APPROXIMATELY FOUR WEEKS TO FACILITATE HEALING. NO DEVICE MALFUNCTION OR FAILURE WAS REPORTED OR IDENTIFIED. THE DEVICE FUNCTIONED AS INTENDED. THE PATIENT RETURNED FOR FOLLOW-UP ON (B)(6) 2026 AND UNDERWENT TREATMENT WITH THE CVAC DEVICE WITHOUT COMPLICATION. NO ADVERSE SEQUELAE RELATED TO THE PRIOR MUCOSAL INJURY WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    132683 CVAC ASPIRATION SYSTEM ENDOSCOPIC ACCESS OVERTUBE, GASTROENTEROLOGY - UROLOGY FED CALYXO, INC. CVC127020-1 89904454

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention URETERAL ACCESS SHEATH: BOSTON SCIENTIFIC 12/14FR.