BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CVAC ASPIRATION SYSTEM

    MDR report key: 22966607 · Received September 4, 2025

    Report

    Report Number
    3014683069-2025-00021
    Event Type
    Injury
    Date Received
    September 4, 2025
    Date of Event
    August 7, 2025
    Report Date
    September 4, 2025
    Manufacturer
    CALYXO, INC.
    Product Code
    FED
    PMA / PMN Number
    K233472
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER FOR INVESTIGATION. 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 NON-CONFORMANCES 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. PER THE CVAC SYSTEM IFU, IF NO UAS IS USED DURING SURE, IT IS REQUIRED TO REMOVE THE WORKING CHANNEL CAP, INSERT THE INTRODUCER (A PROVIDED ACCESSORY) INTO THE WORKING CHANNEL AND THEN ADVANCE THE CVAC SYSTEM AND THE INTRODUCER OVER THE GUIDEWIRE. THE INTRODUCER CAN THEN BE REMOVED WHEN THE TIP OF THE CVAC SYSTEM IS IN THE KIDNEY AND THE CAP REPLACED ON THE WORKING CHANNEL. URETERAL PERFORATION IS A KNOWN RISK OF URETEROSCOPY, INCLUDING THE SURE PROCEDURE, OCCURRING IN UP TO 7.7% OF CASES.

    Description of Event or Problem · 0

    ON (B)(6)2025, A 59 YEAR-OLD MALE WITH COMORBIDITIES OF EHLERS-DANOS SYNDROME (EDS), DIABETES, HYPERTENSION AND HYPERLIPIDEMIA UNDERWENT SURE WITH THE CVAC SYSTEM FOR A RIGHT RENAL PELVIS STONE MEASURING 20 MM AND 1000 HU. THE PATIENT WAS NOT PRE-STENTED, AND THE TREATING PHYSICIAN INSERTED A GUIDEWIRE AND DILATED THE URETER BY ADVANCING THE INNER 12F TROCAR OF A 12/14 URETERAL ACCESS SHEATH (UAS) TO THE LEVEL OF THE MID URETER. THE OUTER SHEATH OF THE UAS WAS NOT USED. THE CVAC SYSTEM WAS THEN ADVANCED OVER THE GUIDEWIRE WITHOUT USE OF THE INTRODUCER, AND UPON REACHING THE PROXIMAL URETER, THE IMAGE DISPLAYED ANATOMY THAT WAS INCONSISTENT WITH BEING IN THE URETERAL LUMEN . A RETROGRADE PYELOGRAM WAS PERFORMED AND REVEALED EXTRAVASATION WITH THE URETER REMAINING INTACT. THE TREATING PHYSICIAN SWITCHED TO A DIGITAL, FLEXIBLE REUSABLE SCOPE, IDENTIFIED THE TRUE URETERAL LUMEN, AND CONFIRMED THE INJURY. THE PROCEDURE WAS HALTED, AND THE PATIENT WAS STENTED. THE STENT WILL REMAIN IN PLACE FOR > 4 WEEKS TO ALLOW THE URETER TO HEAL BEFORE PERFORMING PERCUTANEOUS NEPHROLITHOTOMY (PCNL). THE TREATING PHYSICIAN NOTED EDS PATIENTS CAN PRESENT WITH DIFFICULT ANATOMY, HOWEVER, BELIEVES THE CVAC SYSTEM COULD HAVE CONTRIBUTED TO THE EVENT AS THE INJURY WAS PROXIMAL TO THE MID-URETER, I.E., THE AREA THAT WAS DILATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1822813 CVAC ASPIRATION SYSTEM ENDOSCOPIC ACCESS OVERTUBE, GASTROENTEROLOGY-UROLOGY FED CALYXO, INC. CVC127020-1

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Male Required Intervention