BEUDAMED
    FDA Adverse Event Death Summary report: N

    VIA MICROCATHETER

    MDR report key: 4558722 · Received February 25, 2015

    Report

    Report Number
    3008423090-2015-00003
    Event Type
    Death
    Date Received
    February 25, 2015
    Date of Event
    February 5, 2015
    Report Date
    February 24, 2015
    Manufacturer
    SEQUENT MEDICAL INC.
    Product Code
    KRA
    PMA / PMN Number
    K132652
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS RELATED TO THE VIA 33 DEVICE WHICH WAS USED AND FOUND THAT IT COULD NOT ACCESS TEH ANEURYSM EFFECTIVELY AND WAS REMOVED AND DISCARDED.

    Description of Event or Problem · 1

    THE PT PRESENTED AT THE HOSP WITH A LEFT SIDEWALL MCA ANEURYSM ACUTE SAH (HUNT AND HESS GRADE IV). THE PT IS A (B)(6) MAN WITH HISTORY OF CARDIAC PROBLEMS AND PLATELET DISORDER ON APT FOR HIS CARDIAC PROBLEMS. HE ALSO HAD SYMPTOMS OF 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 DUE TO ANEURYSM MORPHOLOGY AND THE VIA LOST POSITION WHEN WEB WAS ADVANCED. (THE SUBJECT OF THIS REPORT). 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 TO ACCESS WAS NOT SUCCESSFUL SO IT WAS REMOVED AND DISCARDED BECAUSE THE VIA WAS KINKED. 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 PREP FOR IMPLANT. THE PHYSICIAN TRIED AGAIN TO DELIVER THE VIA 27, AND 18" ASAHI WIRE INSIDE IT. WHEN THE VIA WAS IN-PLACE INSIDE THE ANEURYSM HE REMOVED THE WIRE AND OBSERVED THE POSITING 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 PT WAS STILL ANESTHETIZED AS WE LEFT AND THE PT WAS GOING FOR EVD TO BE IMPLANTED. SEQUENT MEDICAL LEARNED ON (B)(6) 2015 THAT THE PT PASSED AWAY ON SUNDAY NIGHT, (B)(6) 2015, AFTER A CARDIAC ARREST ON SATURDAY FOLLOWED BY PULMONARY EDEMA SUNDAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    134361 VIA MICROCATHETER CONTINUOUS FLUSH CATHETER KRA SEQUENT MEDICAL INC. VIA-33-133-01 14070205

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Death| R