BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DISTAL ACCESS CATHETER

    MDR report key: 1644685 · Received March 26, 2010

    Report

    Report Number
    2954917-2010-00003
    Event Type
    Injury
    Date Received
    March 26, 2010
    Date of Event
    March 1, 2010
    Report Date
    March 26, 2010
    Manufacturer
    CONCENTRIC MEDICAL, INC.
    Product Code
    DQY
    PMA / PMN Number
    K090335
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PATIENT WAS (B) (6) FEMALE WHO FELL AT HOME AND WAS CONSIDERED A TRAUMA PATIENT. THE PATIENT WAS DIAGNOSED WITH A BASILAR ARTERY (BA) OCCLUSION. THE PHYSICIAN NOTED EXTREME TORTUOSITY IN THE VERTEBRAL ARTERY AND A VERY TIGHT LOOP DESCRIBED AS A "KINK" IN THE LEFT VERTEBRAL ARTERY. TWO PASSES WITH THE RETRIEVER V 2.5 SOFT RECANALIZED THE BA AND THEN THROMBUS WAS NOTED IN THE LEFT P1 PCA. THE PHYSICIAN ATTEMPTED TO TRACK A PENUMBRA 054 REPERFUSION CATHETER TO THE P1 PCA BUT IT COULD NOT BE NAVIGATED TO THE DESIRED LOCATION IN THE VESSEL. THE PHYSICIAN THEN ATTEMPTED TO TRACK A DAC 057 TO THE P1 PCA BUT IT COULD NOT BE NAVIGATED TO THE DESIRED LOCATION IN THE VESSEL, PAST THE "KINK" NOTED ABOVE. THE PHYSICIAN WAS ABLE TO TRACK A PENUMBRA 041 REPERFUSION CATHETER TO THE P1 PCA AND PERFORMED MANUAL ASPIRATION TO REMOVE THE THROMBUS AND ACHIEVE FULL REVASCULARIZATION. CONTRAST INJECTION POST REVASCULARIZATION DEMONSTRATED CONTRAST EXTRAVASATION NEAR THE SITE OF THE LEFT VERTEBRAL ARTERY LOOP "KINK" AND A PSEUDOANEURYSM FORMING AT THAT LOCATION. THE PHYSICIAN PLACED SOME NEUROEMBOLIZATION COILS INTO THE PSEUDOANEURYSM AND THEN PLACED A COVERED STENT IN THE VESSEL AND INTRA-ARTERIAL INTEGRILIN. THIS STOPPED THE EXTRAVASATION. IT WAS NOTED BY THE PHYSICIAN THAT THE BLEEDING WAS INTO THE NECK TISSUE ONLY AND WAS NOT INTRACRANIAL. THE PHYSICIAN FELT THE USE OF THE DAC CAUSED THE EXTRAVASATION. THE PATIENT WENT ON TO EXPIRE. THE ENTIRE NEUROLOGY STAFF FEELS THAT THE LEFT VERTEBRAL ARTERY EXTRAVASATION DID NOT CAUSE THE PATIENT TO EXPIRE AS IT WAS ONLY IN THE NECK TISSUE. THE TEAM ALL AGREED THERE HAD TO BE BLEEDING ELSEWHERE (POSSIBLY GASTROINTESTINAL) WHICH LED TO THIS OUTCOME. NO DEVICE MALFUNCTIONS WERE REPORTED. THE DAC INSTRUCTIONS FOR USE LISTS VESSEL PERFORATION AS A POSSIBLE COMPLICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DISTAL ACCESS CATHETER CATHETER, PERCUTANEOUS DQY CONCENTRIC MEDICAL, INC. REF 90131 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Required Intervention