BEUDAMED
    FDA Adverse Event Death Summary report: N

    PREFORM GUIDEWIRE - SAFARI

    MDR report key: 4926384 · Received July 20, 2015

    Report

    Report Number
    2126666-2015-00043
    Event Type
    Death
    Date Received
    July 20, 2015
    Date of Event
    June 30, 2015
    Report Date
    July 20, 2015
    Manufacturer
    LAKE REGION MEDICAL
    Product Code
    DQX
    PMA / PMN Number
    K130798
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RECEIVED FOR ANALYSIS; THEREFORE NO PHYSICAL OR VISUAL ANALYSIS OF THE PRODUCT CAN BE PERFORMED. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND INSPECTION SPECIFICATIONS. REVIEW OF THE DFU NOTES THE REPORTED EVENT AS POTENTIAL ADVERSE EVENT ASSOCIATED WITH THE TAVI/TAVR USE OF THE DEVICE. IF THE GUIDEWIRES WERE ONLY INTRODUCED INTO OR WITHDRAWN FROM THE VENTRICLE THROUGH A CATHETER AS REQUIRED BY THE DIRECTIONS FOR USE THE SAFARI GUIDEWIRES WOULD NOT COME INTO CONTACT WITH THE ABDOMINAL AORTA. A COMBINATION OF PATIENT AND PROCEDURAL FACTORS APPEAR TO HAVE CAUSED OR CONTRIBUTED TO THIS INCIDENT. DEVICE NOT RETURNED FOR EVALUATION

    Description of Event or Problem · 1

    THREE SEPARATE SAFARI GUIDEWIRES WERE USED IN THIS ONE CASE SO SEPARATE MDR'S (2126666-2015-00042, 2126666-2015-00043 & 2126666-2015-00044) ARE BEING FILED FOR EACH SAFARI WIRE INVOLVED. PER CNF: PATIENT APPROVED FOR LOTUS IMPLANTATION. TORTUOUS PERIPHERAL ANATOMY BUT WITH BIG ENOUGH DIAMETERS ON BOTH SIDES TO ACCOMMODATE THE LARGE SHEATH. LEFT SIDE ACCESS DECIDED. LOTUS LARGE SHEATH WAS SUCCESSFULLY INSERTED AND VALVE WAS PREPARED AND GIVEN FOR INSERTION. AFTER A WHILE OF CATHETER ADVANCEMENT (STILL ON ILIAC), THE FIRST OPERATOR EXPERIENCED RESISTANCE AND AS WE SAW ON THE SCREEN IT WAS ON THE POSITION OF A CURVE OF THE ILIAC VESSEL. DECISION WAS TAKEN TO STOP, REMOVE THE CATHETER AND CHANGE THE SAFARI WIRE AND TRY TO STRAIGHTENED THE SHEATH BY PARTIALLY REMOVING AND READVANCING IT WITH ITS DILATOR. VALVE WAS KEPT UNDERWATER AND STILL SHEATHED WITHOUT ANY OBVIOUS DAMAGE. THEY TRIED AGAIN WITH SAME RESULTS. THEY AGAIN TOOK THE CATHETER OUT. FOR THE THIRD TIME THEY CHANGED THE SHEATH AND SAFARI WIRE (3RD ONE). FOR THIS TIME, THE VALVE WAS UNSHEATHED, CAREFULLY INSPECTED, FLUSHED AND RE-SHEATHED AGAIN SUCCESSFULLY AND WITHOUT ANY DAMAGE. THEY MANAGED TO ADVANCE THE CATHETER THROUGH THE SHEATH AND THE ANATOMY AND STARTED TO IMPLANT THE VALVE. DURING UNSHEATHING THE VALVE THERE WAS A DROP ON PATIENT`S PRESSURE OBSERVED. THEY TRIED TO IMPLANT THE VALVE QUICKLY BUT THERE WERE 2 EARLY CLICKS OCCURRED BEFORE LOCKING SO THE TEAM DECIDED TO RESHEATH AND REMOVE THE VALVE AND DEAL WITH THE PRESSURE DROP. THEY WERE SUSPECTING A BLEEDING DUE TO SOME DISSECTION SOMEWHERE IN THE ANATOMY. THERE WAS NO ANNULUS RUPTURE ACCORDING TO TRANSTHORACIC ASSESSMENT. THE CONTRAST INJECTION IN ABDOMINAL AORTA SHOWED A SMALL DISSECTION IN THE LOW PART OF ABDOMINAL AORTA CLOSE TO BIFURCATION. DECISION WAS TAKEN TO SURGICALLY TREAT THE PATIENT. THE PATIENT MADE IT THROUGH SURGERY AND CURRENTLY RECOVERING ON A STABLE STATUS. ADDITIONAL INFO RECEIVED ON (B)(6) 2015. THE PATIENT UNFORTUNATELY PASSED AWAY ON (B)(6). AS PER PHYSICIAN SAYINGS THE REASON FOR PATIENT`S DEATH WAS A CARDIOGENIC SHOCK IN SEVERE AF. THIS MIGHT CAME AS RESULT FROM THE ELONGATED OCCLUSION WHICH MIGHT HAVE CAUSED RENAL FAILURE AND EVENTUALLY MULTIPLE ORGANS FAILURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    468340 PREFORM GUIDEWIRE - SAFARI WIRE GUIDE DQX LAKE REGION MEDICAL H74939272S1 10528166

    Patients

    Seq Age Sex Outcome Treatment
    1 Death