BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PREFORM GUIDEWIRE - SAFARI2

    MDR report key: 5704858 · Received June 7, 2016

    Report

    Report Number
    2126666-2016-00060
    Event Type
    Malfunction
    Date Received
    June 7, 2016
    Date of Event
    April 6, 2016
    Report Date
    June 7, 2016
    Manufacturer
    LAKE REGION MEDICAL
    Product Code
    DQX
    PMA / PMN Number
    K151244
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS THE FIRST OF TWO RELATED MDR'S 2126666-2016-00060 AND 2126666-2016-00061. TWO GUIDEWIRES WERE USED IN THE PROCEDURE. THIS MEDWATCH REPORT IS FOR THE FIRST GUIDEWIRE USED IN THIS CASE THAT REPORTEDLY BECAME STUCK IN THE CATHETER. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND INSPECTION SPECIFICATIONS. THE DEVICE WAS NOT RETURNED FOR ANALYSIS AT THE TIME THIS REPORT WAS SUBMITTED; THEREFORE NO PHYSICAL OR VISUAL ANALYSIS COULD BE PERFORMED. A COMBINATION OF PATIENT AND PROCEDURAL FACTORS APPEAR TO HAVE CAUSED OR CONTRIBUTED TO THIS INCIDENT. IF ADDITIONAL INFORMATION IS RECEIVED OR THE PRODUCT IS RETURNED FOR ANALYSIS A FOLLOW-UP MEDWATCH REPORT WILL BE SUBMITTED. NO PRODUCT RETURNED.

    Description of Event or Problem · 1

    A 23MM LOTUS TAVI IN A PATIENT WITH A HORIZONTAL AORTA AND A SMALL LV. VALVE PREP WENT NORMAL ACCORDING TO THE GUIDELINES. NORMAL DEVICE INTRODUCTION, TRACKING THROUGH THE AORTA AND AORTIC ARCH WITH GOOD MARKER ALIGNMENT, VALVE LOCKING WITHOUT ISSUES BUT WITH AI. THE DECISION WAS MADE BY THE IMPLANTERS TO MAKE A PARTIAL AORTIC REPOSITIONING. GW CORRECTION WAS REQUIRED, BUT IT WAS IMPOSSIBLE BY THE SECOND IMPLANTER TO MAKE THE SAFARI 2 GW CORRECTION. IT STUCK IN THE LOTUS CATHETER. THE IMPLANT TEAM DECIDED TO RETRIEVE THE CATHETER TOGETHER WITH THE SAFARI 2 SMALL INTO THE DESCENDING AORTA AND REMOVED BOTH DEVICES TOGETHER FROM THE HEMODYNAMICALLY STABLE PATIENT WITHOUT ISSUES. THE FIRST IMPLANTER REMOVED THE SAFARI FROM THE LOTUS CATHETER BY CUTTING THE SAFARI TIP. THE LOTUS DEVICE WAS OK, NO KINK ETC. A NEW SAFARI 2 XS WAS INTRODUCED AND PLACED WITHOUT ISSUES, BUT THE MANAGEMENT WAS DIFFICULT AND THE IMPLANTERS NOTICED AN INCREASED TENSION INSIDE THE LOTUS SYSTEM DURING THE DEVICE TRACKING, CORRECTION OF AN UNDERSHEATHED NOSECONE IN THE DESCENDING AORTA AND CROSSING THE AORTIC ARCH WITH GOOD MARKER ALIGNMENT. AS THE IMPLANT TEAM WANTED TO CROSS THE ANNULUS THEY NOTICED A FAILED SAFARI 2 XS PLACEMENT, SUDDENLY THE BLOOD PRESSURE DROPPED DOWN. AFTER A 3 MINUTES REANIMATION THE PATIENT WAS HEMODYNAMICALLY STABLE AT THE HLM, CONVERSION TO CS. PATIENT IS RECOVERING AFTER THE CLOSURE OF THE LV PERFORATION AND A SAVR WITH A 23MM TRIFECTA .

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    357578 PREFORM GUIDEWIRE - SAFARI2 WIRE GUIDE DQX LAKE REGION MEDICAL H74939406S1 10623704

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR