BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GUARDIAN II HEMOSTASIS VALVE NO-CLICK

    MDR report key: 3298918 · Received August 20, 2013

    Report

    Report Number
    3005395947-2013-00013
    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
    PMA / PMN Number
    K122301
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    USER FACILITY DID NOT RETURN DEVICE.

    Description of Event or Problem · 1

    (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 ((B)(4)), 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
    401911 GUARDIAN II HEMOSTASIS VALVE NO-CLICK HEMOSTASIS VALVE DTL VASCULAR SOLUTIONS ZERUSA LIMITED 8216 25612

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| R