BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CVAC ASPIRATION SYSTEM

    MDR report key: 23203818 · Received October 2, 2025

    Report

    Report Number
    3014683069-2025-00025
    Event Type
    Injury
    Date Received
    October 2, 2025
    Date of Event
    September 4, 2025
    Report Date
    November 3, 2025
    Manufacturer
    CALYXO, INC.
    Product Code
    FED
    PMA / PMN Number
    K233472
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DC, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS NOT RETURNED FOR INVESTIGATION. THE LOT HISTORY REVIEW (LHR) FOR LOT # 82459709 WAS CONDUCTED, WHICH CONFIRMED THAT THERE WERE NO NON-CONFORMANCES DUIRNG THE MANUFACTURING PROCESS THAT COULD BE RELATED TO THE REPORTED EVENT. THE REVIEW INDICATED THAT THE DEVICE MET ALL DESIGN AND MANUFACTURING SPECIFICATIONS WHEN RELEASED FOR DISTRIBUTION. DURING SURE PROCEDURE FOR RESIDUAL STONE FRAGMENTS POST-PCNL, THE PATIENT SUSTAINED A URETEROPELVIC JUNCTION (UPJ) TEAR. THE PROCEDURE WAS TEMPORARILY INTERRUPTED WHEN IRRIGATION FLUID BECAME DEPLETED AND REQUIRED REPLACEMENT. DUE TO BLEEDING THAT RESULTED IN POOR VISUALIZATION, THE PROCEDURE WAS DISCONTINUED AT APPROXIMATELY 85% STONE CLEARANCE. A URETERAL STENT WAS PLACED FOR A 4-WEEK DURATION. URETERAL PERFORATION IS A RECOGNIZED COMPLICATION OF URETEROSCOPY PROCEDURES AND IS DOCUMENTED IN THE DEVICE'S INSTRUCTIONS FOR USE AS A POTENTIAL ADVERSE EVENT.

    Additional Manufacturer Narrative · 0

    THE MANUFACTURER'S INVESTIGATION IS CURRENTLY IN PROGRESS.

    Description of Event or Problem · 0

    ON (B)(6) 2025 A FEMALE PATIENT UNDERWENT STEERABLE URETEROSCOPIC RENAL EVACUATION (SURE) WITH THE CVAC ASPIRATION SYSTEM TO REMOVE APPROXIMATELY 1.6CM OF "VERY HARD" STONE REMAINING FROM A PERCUTANEOUS NEPHROLITHOTOMY (PCNL) PROCEDURE THREE WEEKS PRIOR. IT WAS REPORTED THAT AFTER LASING FOR OVER 30 MINUTES WITHOUT ANY ISSUE, IRRIGANT FLOW RAN OUT WHILE THE PHYSICIAN WAS IN ACTIVE SUCTION. THE PROCEDURE WAS PAUSED AND WHILE WAITING FOR THE IRRIGATION SOURCE TO BE SET UP AGAIN, BLEEDING WAS NOTED. THE SOURCE OF THE BLEEDING WAS UNABLE TO BE DETERMINED. THE PHYSICIAN DISCONTINUED THE PROCEDURE AT 85% STONE CLEARANCE DUE TO LACK OF VISIBILITY FROM BLEEDING. A URETERAL PERFORATION AT THE URETEROPELVIC JUNCTION (UPJ) WAS OBSERVED UPON REMOVING THE DEVICE FROM THE KIDNEY AND A URETERAL STENT WAS PLACED. THE STENT WILL REMAIN FOR APPROXIMATELY ONE MONTH AND A PROCEDURE WILL BE SCHEDULED FOR A LATER DATE TO REMOVE THE REMAINING STONE FRAGMENTS. THE PATIENT IS REPORTED TO BE DOING OKAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    292231 CVAC ASPIRATION SYSTEM ENDOSCOPIC ACCESS OVERTUBE, GASTROENTEROLOGY-UROLOGY FED CALYXO, INC. CVC127020-1 82459709

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention