BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CVAC ASPIRATION SYSTEM

    MDR report key: 23733025 · Received December 5, 2025

    Report

    Report Number
    3014683069-2025-00031
    Event Type
    Injury
    Date Received
    December 5, 2025
    Date of Event
    November 7, 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
    PA, 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 INJURIES ARE A KNOWN COMPLICATION IN URETEROSCOPIC STONE REMOVAL PROCEDURES, AND STENT PLACEMENT IS SOMETIMES REQUIRED TO FACILITATE HEALING. POST-PROCEDURAL STENT PLACEMENT IS ALSO COMMON PRACTICE, EVEN IN THE ABSENCE OF A URETERAL INJURY. MULTIPLE DEVICES WERE USED INCLUDING DEVICES FROM OTHER MANUFACTURERS DURING THE PROCEDURE. THERE WAS INSUFFICIENT INFORMATION TO ASCERTAIN THE POSSIBILITY THAT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE INJURY RESULTING IN STENT PLACEMENT. 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

    DURING A SURE PROCEDURE ON (B)(6) 2024 WITH A 12/14 BOSTON SCIENTIFIC URETERAL ACCESS SHEATH, URETERAL INJURY WAS NOTED. STENT PLACEMENT WAS CHALLENGING BUT SUCCESSFUL; NO OTHER INTERVENTIONS WERE REQUIRED. PHYSICIAN NOTED THAT THE ETIOLOGY OF THE INJURY WAS UNKNOWN. THE PATIENT WAS STABLE POSTOPERATIVELY AND WAS REPORTED TO BE DOING WELL ON FOLLOW-UP. 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
    2107765 CVAC ASPIRATION SYSTEM ENDOSCOPIC ACCESS OVERTUBE, GASTROENTEROLOGY-UROLOGY FED CALYXO INC. CVC127020-1

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention