BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANGIODYNAMICS MINI STICK MAX

    MDR report key: 18649813 · Received February 6, 2024

    Report

    Report Number
    18649813
    Event Type
    Malfunction
    Date Received
    February 6, 2024
    Date of Event
    August 16, 2023
    Report Date
    September 29, 2023
    Manufacturer
    NAVILYST MEDICAL, INC.
    Product Code
    DRE
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MD
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    PATIENT WAS SCHEDULED FOR A MEDIPORT PLACEMENT. INTERVENTIONAL RADIOLOGY (IR) PHYSICIAN NOTICED KINK IN THE SHEATH OF THE ANGIODYNAMICS MICROPUNCTURE SET, EXCHANGED IT TO A NEW SET AND COMPLETED THE PROCEDURE. FLUOROSCOPY OF CHEST WAS DONE, BUT PHYSICIAN DID NOT RECOGNIZE THE FRAGMENT. POST PROCEDURE IMAGES SHOWED A FOREIGN OBJECT ON PATIENT'S RIGHT VENTRICLE. A PIECE OF MICROPUNCTURE CATHETER HAD FRAGMENTED AND EMBOLIZED TO THE RIGHT ATRIUM (RA) AND RIGHT VENTRICLE (RV). ENDOVASCULAR RETRIEVAL OF THE CATHETER WAS PERFORMED. THE OUTER PORTION OF THE MICROPUNCTURE CATHETER WAS SUCCESSFULLY RETRIEVED, WITH THE INNER PORTION OF THE CATHETER STILL RETAINED BETWEEN THE RA AND RV. PATIENT WILL BE MONITORED AS OUTPATIENT FOR ANY SYMPTOMATIC ARRHYTHMIAS AND FOR ANY WORSENING MITRAL REGURGITATION (MR) WITH ECHOCARDIOGRAM IN 1 MONTH, 3 MONTHS AND 6 MONTHS PER CARDIOLOGY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2092469 ANGIODYNAMICS MINI STICK MAX DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION DRE NAVILYST MEDICAL, INC. 45748 5775751

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Female