BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHRO GUIDEWIRE

    MDR report key: 1700763 · Received May 27, 2010

    Report

    Report Number
    2939204-2010-00696
    Event Type
    Injury
    Date Received
    May 27, 2010
    Report Date
    May 13, 2010
    Manufacturer
    BOSTON SCIENTIFIC - SALT LAKE CITY
    Product Code
    DQX
    PMA / PMN Number
    UNKNOWN
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PMA# OR 510K#: K032146; K002907; K023700 AND K053268. CONCLUSION: ANTICIPATED PROCEDURAL COMPLICATION. THE DEVICE WAS NOT AVAILABLE FOR ANALYSIS. FROM THE INFORMATION PROVIDED THERE WAS NO INDICATION THAT THE DEVICE WAS NOT USED AS IN ACCORDANCE WITH THE LABELING OR THAT THIS CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. HEMORRHAGE, VESSEL PERFORATION AND VESSEL DISSECTION ARE KNOWN AND ANTICIPATED COMPLICATIONS TO THESE TYPES OF PROCEDURES AND ARE NOTED IN THE LABELING. THEREFORE, IT WAS DETERMINED THAT THE REPORTED EVENT WAS AN ANTICIPATED PROCEDURAL COMPLICATION.

    Additional Manufacturer Narrative · 1

    PMA# OR 510K#: K032146; K002907; K023700 AND K053268.COMPLAINT SOURCE - LITERATURE: KAWAKAMI ET AL. NEUROL MED CHIR (TOKYO)2010;50:183-191.

    Description of Event or Problem · 1

    IT WAS REPORTED IN AN ARTICLE IN NEUROL MED CHIR (B)(6) THAT THE PATIENT PRESENTED WITH AN ACUTE ISCHEMIC EMBOLIC STROKE OF THE MIDDLE CEREBRAL ARTERY M1 SEGMENT. IMAGING REVEALED NO VESSEL RECANALIZATION ONE HOUR AFTER INITIATION OF INTRAVENOUS RECOMBINANT TISSUE PLASMINOGEN ACTIVATOR (RT-PA) THERAPY. FOLLOWING MECHANICAL DISRUPTION OF THE CLOT USING A GUIDEWIRE, ANGIOPLASTY WAS PERFORMED FOR CLOT DISRUPTION BY BALLOON INFLATION AT 6 ATM FOR MAXIMUM 30 SECONDS. ANOTHER GUIDEWIRE WAS USED FOR ANGIOPLASTY. CONTRAST EXTRAVASATION HAD OCCURRED DURING THE PROCEDURE. THE PATIENT RECOVERED AND THE PATIENT'S OUTCOME WAS CATEGORIZED AS INDEPENDENT BASED ON THE (B)(6) OF 1 ONE MONTH POST PROCEDURE AND ON THE (B)(6) SCORE OF 1 THREE MONTHS POST PROCEDURE.

    Description of Event or Problem · 1

    IT WAS REPORTED IN AN ARTICLE IN NEUROL MED CHIR (B) (4) THAT THE PATIENT PRESENTED WITH AN ACUTE ISCHEMIC EMBOLIC STROKE OF THE MIDDLE CEREBRAL ARTERY M1 SEGMENT. IMAGING REVEALED NO VESSEL RECANALIZATION ONE HOUR AFTER INITIATION OF INTRAVENOUS RECOMBINANT TISSUE PLASMINOGEN ACTIVATOR (RT-PA) THERAPY. FOLLOWING MECHANICAL DISRUPTION OF THE CLOT USING A GUIDEWIRE, ANGIOPLASTY WAS PERFORMED FOR CLOT DISRUPTION BY BALLOON INFLATION AT 6 ATM FOR MAXIMUM 30 SECONDS. ANOTHER GUIDEWIRE WAS USED FOR ANGIOPLASTY. CONTRAST EXTRAVASATION HAD OCCURRED DURING THE PROCEDURE. THE PATIENT RECOVERED AND THE PATIENT¿S OUTCOME WAS CATEGORIZED AS INDEPENDENT BASED ON THE NATIONAL INSTITUTES OF HEALTH STROKE SCALE (NIHSS) OF 1 ONE MONTH POST PROCEDURE AND ON THE MODIFIED RANKIN SCALE (MRS) SCORE OF 1 THREE MONTHS POST PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHRO GUIDEWIRE WIRE, GUIDE, CATHETER DQX BOSTON SCIENTIFIC - SALT LAKE CITY UNK174

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Other TRANSEND GUIDEWIRE (BOSTON SCIENTIFIC)| GATEWAY BALLOON CATHETER (BOSTON SCIENTIFIC)