BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VIA MICROCATHETER

    MDR report key: 4095805 · Received September 2, 2014

    Report

    Report Number
    3008423090-2014-00002
    Event Type
    Injury
    Date Received
    September 2, 2014
    Date of Event
    August 19, 2014
    Report Date
    September 2, 2014
    Manufacturer
    SEQUENT MEDICAL, INC.
    Product Code
    DQY
    PMA / PMN Number
    K132652
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ACCORDING TO THE DESCRIPTION OF THE CASE, THE WEB IMPLANT WAS IN AN EXCELLENT POSITION, HOWEVER, THE VIA MICROCATHETER WAS DESCRIBED TO ADVANCE, PUSHING THE WEB OUT OF POSITION. BECAUSE THE MICROCATHETER CAUSED THE WEB IMPLANT TO MOVE, LEADING TO AN ANEURYSM PERFORATION, THE EVENT IS BEING REPORTED. HOWEVER, IT IS UNCLEAR WHY THE VIA MICROCATHETER AND SUPPORT CATHETERS ADVANCED. THE WEB ANEURYSM EMBOLIZATION SYSTEM, ALSO USED IN THE CASE, IS NOT AVAILABLE FOR COMMERCIAL SALE IN THE UNITED STATES AND IS CURRENTLY UNDER AN INVESTIGATIONAL DEVICE EXEMPTION, (B)(4).

    Description of Event or Problem · 1

    A 5 MAX DDC CATHETER WAS PLACED IN THE MID-PORTION OF THE BASILAR ARTERY. THE VIA 27 MICROCATHETER WAS ADVANCED INTO THE DOME OF THE BASILAR ARTERY APEX ANEURYSM OVER A 0.016 HEADLINER FLOPPY 200CM MICROWIRE. THE MICROWIRE WAS REMOVED AND THE 6X3 WEB DL EMBOLIZATION DEVICE WAS ADVANCED THROUGH THE VIA 27 MICROCATHETER AND DEPLOYED IN THE BASILAR APEX UNDER DIRECT FLUOROSCOPIC GUIDANCE. INITIALLY, EXCELLENT POSITIONING AND CONFIRMATION OF THE WEB DEVICE IN THE ANEURYSM WAS SEEN, BUT SUBSEQUENT TO THIS THE VIA CATHETER WAS SEEN TO ADVANCE FORWARD, CREATING A DEEPER RECESS IN THE WEB (PUSHED THE WEB IMPLANT) AND LIKELY PUT PRESSURE ON THE ANEURYSM DOME RESULTING IN PERFORATION. IT WAS ALSO OBSERVED THAT THE ENTIRE SYSTEM INCLUDING THE 5 MAX DDC SYSTEM ADVANCED AS WELL. DSA WAS PERFORMED AFTER DEPLOYMENT OF THE WEB THAT SHOWED A SMALL AMOUNT OF EXTRAVASATION (BLEEDING) AT THE APEX OF THE ANEURYSM. THE WEB DEVICE WAS DETACHED RAPIDLY AND THE VIA 27 CATHETER AND WEB DELIVERY WIRE/SYSTEM WERE REMOVED FROM THE PATIENT. A 7X4 HYPERFORM BALLOON WAS ADVANCED TO THE NECK OF THE ANEURYSM AND INFLATED FOR 3 MINUTES TIME. REPEAT DSA WAS PERFORMED AFTER THE BALLOON WAS DEFLATED AND NO EXTRAVASATION (BLEEDING) WAS VISIBLE AT THAT TIME. A DYNA CT NON-CONTRAST WAS PERFORMED SHOWING A SMALL AMOUNT OF SAH (SUBARACHNOID HEMORRHAGE) IN THE INTERPEDUNCULAR AND PERIMESENCEPHALIC CISTERNS, WITH NO IVH OR HYDROCEPHALUS NOTED. THE PATIENT TOLERATED THE PROCEDURE WELL AND WAS NEUROLOGICALLY INTACT FOLLOWING COMMANDS BRISKLY AFTER THE PROCEDURE. THE PATIENT HAD NO SEQUELAE THE FOLLOWING DAY AND WAS SENT HOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    532303 VIA MICROCATHETER CONTINUOUS FLUSH CATHETER DQY SEQUENT MEDICAL, INC. VIA-27-154-01 14071501

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Hospitalization| L| R