BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COAXIAL MICROINTRODUCER KIT MINI STICK MAX

    MDR report key: 9840252 · Received March 16, 2020

    Report

    Report Number
    MW5093777
    Event Type
    Injury
    Date Received
    March 16, 2020
    Date of Event
    March 8, 2020
    Report Date
    March 13, 2020
    Manufacturer
    ANGIODYNAMICS, INC. / NAVILYST MEDICAL, INC.
    Product Code
    DRE
    UDI-DI
    H965457560
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING CARDIAC CATH FOR STEMI, ANGIODYNAMICS MINI STICK MAX COAXIAL MICROINTRODUCER KIT USED, SHEATH 5FX10CM, NEEDLE 70 MM ECHOGENIC, WIRE NITINOL TUNGSTEN, REF 45-756, LOT 5561860, UPN (B)(4), EXP 12/31/2022 USED. PT MOVED DURING THE PROCEDURE AND WHEN CARDIOLOGIST TRIED TO REMOVE WIRE, IT BECAME ENTRAPPED IN THE VESSEL AND ITS FRAGMENT WAS DISLODGED IN SUBINTIMAL SPACE OF EXTERNAL ILIAC ARTERY. CARDIOLOGIST UNABLE TO REMOVE FRAGMENT. WHEN THE WIRE REMOVED (THE REMAINING WIRE NOT THE FRAGMENT), IT WAS NOTED THE WIRE HAD BECAME UNRAVELED AND "LOOKED LIKE A SPRING". VASCULAR SURGERY CONSULTED REGARDING EXTRACTION OF ENTRAPPED WIRE FRAGMENT, HOWEVER, OPEN SURGERY FOR RETRIEVAL NOT INDICATED. PER VASCULAR SURGEON, WIRE FRAGMENT IS SUBINTIMAL AND THEREFORE UNLIKELY TO REPRESENT AN EMBOLIC SOURCE OR NIDUS. COVERED STENT TO THE AREA CONSIDERED BUT DETERMINED NOT TO BE NEEDED. FULL DISCLOSURE TO FAMILY. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    301606 COAXIAL MICROINTRODUCER KIT MINI STICK MAX DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION DRE ANGIODYNAMICS, INC. / NAVILYST MEDICAL, INC. 45756 5561860 H965457560

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Other