BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FG GATEWAY MR JP 2.00MM X 9MM

    MDR report key: 5049441 · Received September 2, 2015

    Report

    Report Number
    3008853977-2015-00368
    Event Type
    Injury
    Date Received
    September 2, 2015
    Date of Event
    May 4, 2015
    Report Date
    August 12, 2015
    Manufacturer
    BOSTON SCIENTIFIC - MINN
    Product Code
    GBA
    PMA / PMN Number
    H050001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    SUBJECT DEVICE IS NOT AVAILABLE.

    Additional Manufacturer Narrative · 1

    A DEVICE HISTORY RECORD REVIEW COULD NOT BE PERFORMED AS THE LOT NUMBER OF THE DEVICE IS UNKNOWN. THE DEVICE WAS NOT RETURNED FOR ANALYSIS THEREFORE VISUAL INSPECTION AND FUNCTIONAL TESTING COULD NOT BE PERFORMED. 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 IS A KNOWN AND ANTICIPATED COMPLICATIONS TO THESE TYPES OF PROCEDURES AND IS NOTED IN THE LABELING. THEREFORE, IT WAS DETERMINED THAT THE REPORTED EVENT WAS AN ANTICIPATED PROCEDURAL COMPLICATION.

    Description of Event or Problem · 1

    IT WAS REPORTED IN A POST MARKETING SURVEILLANCE REPORT THAT A SUBARACHNOID HEMORRHAGE (SAH) OCCURRED IN THE TREATED LESION DURING THE PROCEDURE. THE TARGET LESION WAS LEFT M1 DISTAL. THROMBUS ASPIRATION WAS PERFORMED WITH AN ASPIRATION CATHETER BUT IT DID NOT WORK. TWO PASSES WITH A RETRIEVAL SYSTEM WERE THEN PERFORMED AND ANGIOPLASTY WAS DONE 3 TIMES WITH A BALLOON (SUBJECT DEVICE). REPERFUSION WAS ACHIEVED BUT THE SAH OCCURRED IN THE TREATED AREA. NO MEDICAL TREATMENT WAS PERFORMED FOR THE SAH AS IT WAS NOT SERIOUS.

    Description of Event or Problem · 1

    IT WAS REPORTED IN A POST MARKETING SURVEILLANCE REPORT THAT A SUBARACHNOID HEMORRHAGE (SAH) OCCURRED IN THE TREATED LESION DURING THE PROCEDURE. THE TARGET LESION WAS LEFT M1 DISTAL. THROMBUS ASPIRATION WAS PERFORMED WITH AN ASPIRATION CATHETER BUT IT DID NOT WORK. TWO PASSES WITH A RETRIEVAL SYSTEM WERE THEN PERFORMED AND ANGIOPLASTY WAS DONE 3 TIMES WITH A BALLOON (SUBJECT DEVICE). REPERFUSION WAS ACHIEVED BUT THE SAH OCCURRED IN THE TREATED AREA. NO MEDICAL TREATMENT WAS PERFORMED FOR THE SAH AS IT WAS NOT SERIOUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    580500 FG GATEWAY MR JP 2.00MM X 9MM CATHETER, BALLOON TYPE GBA BOSTON SCIENTIFIC - MINN UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR Other