BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TELEFLEX VSL MICRO-INTRODUCER KIT 5FR

    MDR report key: 9117093 · Received September 24, 2019

    Report

    Report Number
    MW5090001
    Event Type
    Injury
    Date Received
    September 24, 2019
    Date of Event
    September 19, 2019
    Report Date
    September 20, 2019
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    DYB
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    WHEN INSERTING MICRO PUNCTURE SHEATH AND THE CARDIOLOGIST ATTEMPTED TO INSERT WIRE AFTER REMOVAL OF DILATOR AND WHEN THE WIRE WOULD NOT GO, HE ATTEMPTED TO REMOVE INTRODUCER AND THE HUB SNAPPED OFF AND THE CATHETER WAS BELOW THE SKIN LEVEL AND THE DISTAL END WAS IN THE LEFT FEMORAL ARTERY. ANOTHER PROVIDER WAS CONSULTED AND TOGETHER THEY RETRIED THE CATHETER USING A SNARE. THEY ATTEMPTED TO GO FROM THE RIGHT RADIAL AND WAS SUCCESSFUL FROM THE LEFT FEMORAL. THE REST OF THE CATHETERIZATION AND THE PTCA PROCEEDED WITHOUT DIFFICULTY. THE EQUIPMENT WAS: VSI MICRO-INTRODUCER KIT 5FR. REF 7256V, LOT # 252619, EXPIRATION 2022-05-31. FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    902761 TELEFLEX VSL MICRO-INTRODUCER KIT 5FR INTRODUCER, CATHETER DYB TELEFLEX MEDICAL 652619

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Required Intervention