BEUDAMED
    FDA Adverse Event Death Summary report: N

    PREFORM GUIDEWIRE - SAFARI2

    MDR report key: 6193125 · Received December 21, 2016

    Report

    Report Number
    2126666-2016-00102
    Event Type
    Death
    Date Received
    December 21, 2016
    Date of Event
    December 8, 2016
    Report Date
    December 21, 2016
    Manufacturer
    LAKE REGION MEDICAL
    Product Code
    DQX
    PMA / PMN Number
    K151244
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RECEIVED FOR ANALYSIS; THEREFORE, NO PHYSICAL OR VISUAL ANALYSIS OF THE PRODUCT CAN BE PERFORMED. REVIEW OF THE DEVICE HISTORY RECORDS FOR THE LOT PROVIDED REVEALED ALL PRODUCT MET MATERIAL, ASSEMBLY AND INSPECTION REQUIREMENTS PRIOR TO SHIPMENT. REVIEW OF THE DFU NOTES THE REPORTED EVENT AS A POTENTIAL ADVERSE EVENT ASSOCIATED WITH THE TAVR/TAVI PROCEDURE. THE PRODUCT IS NOT EXPECTED TO BE RETURNED; HOWEVER, IF ADDITIONAL INFORMATION IS RECEIVED A FOLLOW-UP MEDWATCH WILL BE FILED. PRODUCT DISPOSED.

    Description of Event or Problem · 1

    AS RECEIVED: "STARTING THE LOTUS PROCEDURE, WHILE INTRODUCING THE CATHETER ABDOMINAL BLEEDING OCCURRED JUST ABOVE THE BIFURCATION RIGHT ILLIAC/ABDOMINAL. SAFARI WIRE 2 WAS USED. DURING INTRODUCTION OF THE CATHETER THE LV WAS IN VIEW (USUAL PRACTICE OF THE CENTRE) WIRE WAS NOT BUCKLING. SECOND OPERATOR HAD TENSION ON THE WIRE WHILE ADVANCING. SOME RESISTANCE WAS FELT BY THE FIRST OPERATOR. MOVED TABLE TO HAVE A LOOK AT ILLIACS. VALVE WAS NO LONGER INSIDE THE ARTERY BUT PUNCTURED THE WALL. A SMALL CURL WAS SEEN IN THE SAFARI WIRE. AS A RESULT A MAJOR BLEEDING OCCURRED, A 30MM BALLOON WAS PLACED. VASCULAR SURGEON CAME IN BUT SAID IT WAS TOO MUCH DAMAGE TO FIX. FINALLY THE PATIENT DID NOT SURVIVE. PHYSICIANS THINK IT HAD NOT TO DO WITH THE DEVICE. SHOULD HAVE STOPPED ADVANCING THE FIRST MOMENT RESISTANCE WAS FELT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    844951 PREFORM GUIDEWIRE - SAFARI2 WIRE GUIDE DQX LAKE REGION MEDICAL H74939406S1 10702460

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Death