BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GUARDIAN HEMOSTASIS VALVE NO-CLICK

    MDR report key: 3299029 · Received August 20, 2013

    Report

    Report Number
    2134812-2013-00028
    Event Type
    Injury
    Date Received
    August 20, 2013
    Date of Event
    September 22, 2012
    Report Date
    August 20, 2013
    Manufacturer
    VASCULAR SOLUTIONS ZERUSA LIMITED
    Product Code
    DTL
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    MN, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    THE EVENT WAS REPORTED THROUGH FDA MEDWATCH PROGRAM BY THE USER FACILITY, AND IS DESCRIBED IN A MEDWATCH REPORT ((B)(4)). THE PATIENT ARRIVED IN THE CATH LAB IN AN EMERGENT SITUATION. AFTER COMPLETION OF A THROMBECTOMY PROCEDURE, AIR WAS NOTICED IN A CORONARY ARTERY. THE PATIENT SUBSEQUENTLY EXPERIENCED BRADYCARDIA, VENTRICULAR TACHYCARDIA, AND CARDIAC ARREST. THE PATIENT RECOVERED AND WAS DISCHARGED HOME. EIGHT MONTHS LATER, WHEN THE FACILITY BECAME AWARE OF A RECALL (FDA# Z-0955-2013), THE USER FACILITY SUBMITTED A MEDWATCH REPORT STATING THAT A GUARDIAN DEVICE WAS USED DURING THE PROCEDURE. THE STATEMENT IN THE MEDWATCH REPORT THAT THE "DEVICE USED DURING PROCEDURE WAS PART OF A RECALL BY FDA" IS INCORRECT; THE GUARDIAN USED IN THE PROCEDURE WAS NOT WITHIN THE SCOPE OF THE RECALL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    401406 GUARDIAN HEMOSTASIS VALVE NO-CLICK HEMOSTASIS VALVE DTL VASCULAR SOLUTIONS ZERUSA LIMITED 8216 25612

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| R