BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANGIODYNAMICS MICROPUNCTURE KIT-MINI STICK MAX

    MDR report key: 19829125 · Received July 24, 2024

    Report

    Report Number
    MW5157595
    Event Type
    Injury
    Date Received
    July 24, 2024
    Date of Event
    November 7, 2023
    Report Date
    July 22, 2024
    Manufacturer
    NAVILYST MEDICAL, INC./ANGIODYNAMICS, INC.
    Product Code
    DRE
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NJ, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    HE HAD SVT (SUPRAVENTRICULAR TACHYCARDIA) (AFIB/FLUTTER WITH PERIODS OF FOCAL ATRIAL TACHYCARDIA) DURING THESE EPISODES OF BLEEDING AND WITH CHF (CONGESTIVE HEART FAILURE) EXACERBATION TREATED WITH IV DIURETICS ALONG WITH METOPROLOL AND DIGOXIN. DURING A RIGHT HEART CATHETERIZATION A RETAINED WIRE FRAGMENT WAS NOTED IN THE INFERIOR VENA CAVA ON (B)(6) 2024. WIRE WAS EXTRACTED ON (B)(6) 2024 BY INTERVENTIONAL RADIOLOGY. ON (B)(6) 2023 PROCEDURE OPERATOR WAS NOTIFIED AND AFTER REVIEW OF THE CASE IT WAS REVEALED THERE WAS RESISTANCE ADVANCING THE WIRE WHICH HAD RIBBONED WHEN REMOVED. AT THE TIME THE OPERATOR DID NOT SUSPECT ANY RETAINED FOREIGN BODY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    534102 ANGIODYNAMICS MICROPUNCTURE KIT-MINI STICK MAX DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION DRE NAVILYST MEDICAL, INC./ANGIODYNAMICS, INC. 579457

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Male Hospitalization| R