BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CVAC ASPIRATION SYSTEM

    MDR report key: 21339732 · Received February 7, 2025

    Report

    Report Number
    3014683069-2025-00002
    Event Type
    Injury
    Date Received
    February 7, 2025
    Date of Event
    December 1, 2024
    Report Date
    May 22, 2025
    Manufacturer
    CALYXO, INC.
    Product Code
    FED
    PMA / PMN Number
    K233472
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE HOSPITAL SUBMITTED A MEDSUN REPORT# (B)(4). CALYXO HAS IDENTIFIED TWO OF THE PATIENTS LISTED IN THIS REPORT AS MFR# 3014683069-2024-00001 (PATIENT 1) AND MFR# 3014683069-2025-00001 (PATIENT 2). THIS CURRENT REPORT IS FOR PATIENT 3 LISTED IN THE MEDSUN REPORT. B3 EVENT DATE: THE SPECIFIC DATE OF EVENT IS UNKNOWN. THE MANUFACTURER'S INVESTIGATION IS CURRENTLY IN PROCESS.

    Additional Manufacturer Narrative · 0

    CALYXO INC. MADE MULTIPLE FOLLOW UP ATTEMPTS WITH THE REPORTING HOSPITAL AND TREATING PHYSICIAN TO OBTAIN ADDITIONAL DETAILS REGARDING THE REPORTED EVENT; NO RESPONSE WAS RECEIVED BY THE HOSPITAL STAFF OR THE TREATING PHYSICIAN. THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER FOR INVESTIGATION. THE SPECIFIC LOT NUMBER OF THE DEVICE USED DURING THIS PROCEDURE WAS NOT REPORTED TO CALYXO; HOWEVER, A LOT 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. RENAL BLEEDING IS A KNOWN RISK OF URETEROSCOPY PROCEDURES, INCLUDING THE SURE PROCEDURE. BLEEDING COMPLICATIONS HAVE BEEN DOCUMENTED IN APPROXIMATELY 0.6% TO 1.5% OF URETEROSCOPY PROCEDURES AND THE ASPIRE PIVOTAL TRIAL, WHICH COMPARED SURE TO STANDARD URETEROSCOPY, DEMONSTRATED SIMILAR SAFETY PROFILES. AS SUCH, THERE IS NO CLINICAL EVIDENCE THAT SHOWS THE SURE PROCEDURE WITH THE CVAC SYSTEM LEADS TO AN INCREASED RISK OF RENAL BLEEDING WHEN COMPARED TO URETEROSCOPY PROCEDURES.

    Description of Event or Problem · 0

    ON 04-DEC-2024 CALYXO WAS PROVIDED WITH A COPY OF MEDSUN REPORT # (B)(4). THIS REPORT WAS FOR A DIFFERENT PATIENT EVENT (MDR# 3014683069-2024-00001). IN THIS REPORT, THE HOSPITAL HAD ALSO LISTED INFORMATION RELATED TO THIS CURRENT REFERENCED PATIENT AS "WE HAVE EXPERIENCED THREE EPISODES OF RENAL BLEEDING ASSOCIATED WITH CYSTOSCOPY USING THIS 2ND GENERATION DEVICE. WE SUSPECT THAT THE BLEEDING EPISODES WERE THE RESULT OF AN INCREASE IN IN RENAL PRESSURE, LIKELY DUE TO HOW THE SCOPE ALLOWS FOR DRAINAGE AND ENABLES SUCTION. WE SUSPECT THAT THE LACK OF SUFFICIENT DRAINAGE AND/OR APPROPRIATE SUCTION LEADS TO INCREASED INTRA-RENAL PRESSURE, RESULTING IN POTENTIAL TRAUMA/BLEEDING FOR PATIENTS." CALYXO HAS REACHED OUT TO THE REPORTING HOSPITAL TO OBTAIN FURTHER INFORMATION ON THIS PATIENT EVENT; HOWEVER, TO DATE WE HAVE NOT RECEIVED ANY INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    110515 CVAC ASPIRATION SYSTEM CVAC ASPIRATION SYSTEM FED CALYXO, INC. CVC127020-1

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other 12/14 FRENCH URETERAL ACCESS SHEATH.