BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CVAC ASPIRATION SYSTEM

    MDR report key: 22006732 · Received May 12, 2025

    Report

    Report Number
    3014683069-2025-00011
    Event Type
    Injury
    Date Received
    May 12, 2025
    Date of Event
    September 11, 2024
    Report Date
    June 13, 2025
    Manufacturer
    CALYXO, INC.
    Product Code
    FED
    PMA / PMN Number
    K233472
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE MANUFACTURER'S INVESTIGATION IS CURRENTLY IN PROGRESS.

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS NOT RETURNED FOR INVESTIGATION. THE SPECIFIC LOT NUMBER OF THE DEVICE USED DURING THIS PROCEDURE WAS NOT REPORTED TO CALYXO; HOWEVER, A LOT OF HISTORY REVIEW (LHR) OF ALL DEVICES SHIPPED TO THE ACCOUNT WAS PERFORMED WHICH CONFIRMED THAT THERE WERE NO NON-CONFORMANCES DURING THE MANUFACTURING PROCESS THAT COULD BE RELATED TO THE REPORTED EVENT. THE REVIEW INDICATED THAT THESE POTENTIAL LOT NUMBERS MET ALL DESIGN AND MANUFACTURING SPECIFICATIONS WHEN RELEASED FOR DISTRIBUTION. UNPLANNED HOSPITALIZATIONS HAVE BEEN DOCUMENTED TO OCCUR IN UP 5% OF URETEROSCOPIC CASES.

    Description of Event or Problem · 0

    ON (B)(6) 2024, AN 83-YEAR-OLD FEMALE PATIENT WITH BILATERAL NEPHROLITHIASIS UNDERWENT A URETEROSCOPIC STONE REMOVAL PROCEDURE ON THE LEFT SIDE WITH THE CVAC ASPIRATION SYSTEM. BASELINE STONE BURDEN ON THE LEFT SIDE WAS 15-18MM WITH THE STONE POSITIONED IN THE LOWER POLE. DURING THE PROCEDURE, THE TREATING PHYSICIAN EXPERIENCED DIFFICULTIES WITH VISIBILITY USING THE CVAC SYSTEM, ATTEMPTED TO COMPLETE THE CASE WITH AN ALTERNATE SCOPE WHICH ALSO PROVIDED INADEQUATE VISIBILITY, AND THEN ABORTED THE PROCEDURE. SEVERAL MONTHS LATER, ON (B)(6) 2025, CALYXO INC. WAS INFORMED THAT THE PATIENT HAD BEEN ADMITTED TO THE ICU POST-OPERATIVELY DUE TO TACHYCARDIA AND HYPOTENSION. THE PATIENT WAS TREATED MEDICALLY WITH VASOPRESSORS FOR 5 DAYS AND RECOVERED. ADDITIONAL DETAILS BECAME AVAILABLE ON (B)(6) 2025 WHEN THE FDA PROVIDED CALYXO INC. WITH A MEDWATCH REPORT (REPORT #MW5169256) SUBMITTED BY THE TREATING PHYSICIAN. IN THE REPORT, THE PHYSICIAN NOTED THAT THE PROCEDURE WAS ABORTED DUE TO SUPRA-PHYSIOLOGIC PRESSURES, WHICH WERE BELIEVED TO HAVE CONTRIBUTED TO THE ICU ADMISSION FOR MANAGEMENT OF HYPERDYNAMIC RESPONSE, I.E., TACHYCARDIA AND HYPOTENSION REQUIRING VASOPRESSOR SUPPORT. IN (B)(6) 2025, CALYXO INC. INITIATED AN INVESTIGATION AND SPOKE TO THE TREATING PHYSICIAN TO GATHER FURTHER INFORMATION. THE PHYSICIAN ACKNOWLEDGED THE PROCEDURE WAS CHALLENGING FOR CVAC AND WOULD HAVE BEEN CHALLENGING USING STANDARD URETEROSCOPY. ADDITIONALLY, ALTHOUGH THE PREOPERATIVE URINE CULTURE WAS NEGATIVE, "ATYPICAL," HIGH-VISCOSITY URINE WAS ENCOUNTERED ONCE THE DEVICE WAS IN THE KIDNEY. THE IRRIGATION SETUP USED WAS IN ACCORDANCE WITH THE CVAC SYSTEM INSTRUCTIONS FOR USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1825177 CVAC ASPIRATION SYSTEM ENDOSCOPIC ACCESS OVERTUBE, GASTROENTEROLOGY-UROLOGY FED CALYXO, INC. CVC127020-1

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Female Hospitalization| R