BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERCLOSE

    MDR report key: 5839527 · Received August 2, 2016

    Report

    Report Number
    5839527
    Event Type
    Malfunction
    Date Received
    August 2, 2016
    Date of Event
    April 26, 2016
    Report Date
    June 3, 2016
    Manufacturer
    ABBOTT VASCULAR
    Product Code
    MGB
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A PERFORATION OCCURRED DURING PERCLOSE DEPLOYMENT. A COVERED STENT WAS INSERTED AND DEPLOYED, AND THE PERFORATION WAS REPAIRED. THERE WAS A CHANGE IN RT DP AND PT PULSES AND LT PT PULSE. WE ATTEMPTED TO PLACE AN IMPELLA DEVICE AND WENT FROM 7FR SHEATH TO 14 FR SHEATH, BUT AN ANGIOGRAM SHOWED THE SHEATH TO BE OCCLUDED AT THE DISTAL END. THE SHEATH WAS PULLED AND ATTEMPTED PLACEMENT OF PERCLOSE HOWEVER, IT APPEARED THE FOOT PLATE CAME THROUGH THE ARTERIOTOMY AND MAY HAVE RUPTURED THE VESSEL. ULTIMATELY A VIABAHN COVERED STENT WAS PLACED ACROSS THE PERFORATION SUCCESSFULLY. PERCLOSE LOT # 6012041. NO OTHER IDENTIFYING INFORMATION IS AVAILABLE REGARDING THIS DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    492537 PERCLOSE DEVICE, HEMOSTASIS, VASCULAR MGB ABBOTT VASCULAR 6012041

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Other