BEUDAMED
    FDA Adverse Event Death Summary report: N

    VIA MICROCATHETER

    MDR report key: 4510080 · Received February 10, 2015

    Report

    Report Number
    3008423090-2015-00001
    Event Type
    Death
    Date Received
    February 10, 2015
    Date of Event
    February 5, 2015
    Report Date
    February 10, 2015
    Manufacturer
    SEQUENT MEDICAL INC.
    Product Code
    KRA
    PMA / PMN Number
    K132652
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CASE INFORMATION INDICATED THAT THE VIA 27 MICROCATHETER WAS NAVIGATED SUCCESSFULLY OVER AN 018" ASAHI GUIDEWIRE AND PLACED INSIDE THE ANEURYSM. WHEN THE VIA WAS IN-PLACE INSIDE THE ANEURYSM THE PHYSICIAN REMOVED THE WIRE AND OBSERVED THE POSITION OF THE CATHETER. ONLY THE VIA CATHETER IS INSIDE THE ANEURYSM AT THIS TIME. SUDDENLY THE CATHETER MOVES DISTAL INTO THE ANEURYSM RUPTURING THE WALL AND EXTRAVASATION (BLEEDING) IS OBSERVED ON THE SCREEN. THERE HAVE BEEN APPROXIMATELY 941 CLINICAL USES OF THE VIA MICROCATHETER AND THIS IS THE THIRD REPORTED EVENT OF THIS TYPE ((B)(4) PERCENT), THEREFORE, OTHER PROCEDURAL FACTORS MAY HAVE CONTRIBUTED TO THE EVENT INCLUDING: THE PATIENT'S PRE-EXISTING CONDITION, ADMITTED WITH SAH AND HAD A H AND H SCORE OF IV; CONTROL OF THE SYSTEM OF CATHETER AND GUIDEWIRES BEING USED IN THE CASE AND; IT WAS ALSO NOTED THAT DURING THE CASE MORE THAN ONE VIA CATHETER WAS USED AND THAT ACCESS WAS CHALLENGING (I.E. PATIENT ANATOMY). THE INSTRUCTIONS FOR USE CLEARLY DEFINE THE POTENTIAL COMPLICATIONS, INCLUDING VESSEL PERFORATION, VESSEL OCCLUSION AND STROKE. WITHOUT THE ACTUAL DEVICE TO PERFORM AN INVESTIGATION, THE DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED AND ADDITIONAL TESTING ON A UNIT FROM THE SAME LOT IS PLANNED. THE FILE WILL BE UPDATED WHEN THE INFORMATION BECOMES AVAILABLE. (H AND H SCORE OF IV IS DEFINED AS: STUPOR, MODERATE TO SEVERE HEMIPARESIS).

    Description of Event or Problem · 1

    THE PATIENT PRESENTED AT THE HOSPITAL WITH A LEFT MCA ANEURYSM ACUTE SAH (HUNT AND HESS GRADE IV). THE PATIENT IS A (B)(6) YEAR OLD MAN WITH HISTORY OF CARDIAC PROBLEMS AND PLATELET DISORDER ON APT FOR HIS CARDIAC PROBLEMS. HE ALSO HAD RIGHT HEMIPLEGIA VISIBLE ON CT. THE ORIGINAL PLAN WAS TO USE VIA 33 (AKA VIA PLUS) AND 10MM BUT IT WAS NOT POSSIBLE TO ACCESS THE ANEURYSM WITH VIA 33. THE PHYSICIAN REVIEWED THE SIZING AFTER THE DSA AND DECIDED TO USE A 9MM WEB SO HE SWITCHED TO A VIA 27 CATHETER WITH 18" ASAHI WIRE. THIS ATTEMPT AT ACCESS WAS NOT SUCCESSFUL SO IT WAS REMOVED AND DISCARDED BECAUSE THE VIA WAS KINKED. (FILE (B)(4), INITIATED). A SECOND VIA 27 WAS DELIVERED IN THE SAME WAY BUT WHEN THE 9MM SLS WAS PASSED THROUGH THE CATHETER IT BACKED OUT AND THE WEB WAS RE-SHEATHED. THE WEB DEVICE WAS PLACED ON THE TROLLEY IN PREPARATION FOR IMPLANT. THE PHYSICIAN TRIED TO AGAIN DELIVER THE VIA 27 WITH THE 18" ASAHI WIRE INSIDE IT. WHEN THE VIA WAS IN-PLACE INSIDE THE ANEURYSM HE REMOVED THE WIRE AND OBSERVED THE POSITION OF THE CATHETER. ONLY THE VIA CATHETER IS INSIDE THE ANEURYSM AT THIS TIME. SUDDENLY THE CATHETER MOVES DISTAL INTO THE ANEURYSM RUPTURING THE WALL AND EXTRAVASATION IS OBSERVED ON THE SCREEN. THE PHYSICIAN PREPARED A HYPERGLIDE 4 X 20MM BALLOON AND INFLATED IT ACROSS THE NECK OF THE ANEURYSM. THE OTHER GROIN WAS PUNCTURED AND AN ECHELON CATHETER DELIVERED TO THE ANEURYSM READY FOR COIL DELIVERY. PROTAMINE AND MANNITOL WERE ALSO GIVEN AT THIS TIME TO CONTROL THE BLEEDING AND INCREASED BLOOD PRESSURE. HOWEVER, DESPITE DELIVERING SEVERAL COILS THE BLEEDING CONTINUED AND THEREFORE THE PHYSICIAN DECIDED TO OCCLUDE THE M1 VESSEL WITH COILS. NOW THE BLEEDING STOPPED AND THE PROCEDURE WAS FINISHED. THE PATIENT WAS STILL ANESTHETIZED AS WE LEFT AND THE PATIENT WAS GOING FOR AN EVD TO BE IMPLANTED. SEQUENT MEDICAL LEARNED ON (B)(6) 2015 THAT THE PATIENT PASSED AWAY SUNDAY NIGHT AFTER A CARDIAC ARREST ON SATURDAY FOLLOWED BY PULMONARY EDEMA YESTERDAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    97294 VIA MICROCATHETER CONTINUOUS FLUSH CATHETER KRA SEQUENT MEDICAL INC. VIA-27-154-01 14092603

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Death| R