BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION

    MDR report key: 24860368 · Received April 13, 2026

    Report

    Report Number
    MW5186752
    Event Type
    Injury
    Date Received
    April 13, 2026
    Date of Event
    April 6, 2026
    Report Date
    April 8, 2026
    Manufacturer
    ANGIODYNAMICS, INC.
    Product Code
    DRE
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IL, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    PORTION OF SHEATH CANNULA BROKE OFF PRIOR TO EXCHANGE OF 9 FR SHEATH. ATTEMPTS WERE MADE TO RETRIEVE TRANSLUCENT PIECE USING A SNARE DURING PROCEDURE. KIT MICROINTRODUCER L7 CM MAX COAX STIFFEN GW ECHOGENIC NDL, LOT # 0001309155, DOE (B)(6) 2028; KIT MICROINTRODUCER L7 CM MAX COAX STIFFEN GW ECHOGENIC NDL, LOT #5860435, DOE (B)(6) 2028. COULD BE EITHER OF THESE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    928567 DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION DRE ANGIODYNAMICS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Male Hospitalization