BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GATEWAY PTA DILATATION CATHETER

    MDR report key: 1013316 · Received March 10, 2008

    Report

    Report Number
    2939204-2008-00082
    Event Type
    Injury
    Date Received
    March 10, 2008
    Date of Event
    February 12, 2008
    Report Date
    February 12, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORP.
    Product Code
    LIT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED DURING AN EMBOLIZATION PROCEDURE, A BALLOON CATHETER WAS DEPLOYED NEAR THE NECK OF THE ANEURYSM, AND SIX NON-BOSTON SCIENTIFIC COILS WERE IMPLANTED. HOWEVER, THE COILS WERE ALLEGEDLY DISRUPTED UPON REMOVAL OF THE BALLOON CATHETER ALTHOUGH WERE STILL ENCLOSED WITHIN THE ANEURYSM. AN ANGIOGRAPHY REVEALED A COIL HAD MIGRATED TO THE MIDDLE CEREBRAL ARTERY (MCA). THE PHYSICIAN DECIDED TO FASTEN THE COIL TO THE VESSEL WALL WITH THE BALLOON CATHETER IN QUESTION. WHEN THE BALLOON WAS INFLATED AT 6ATMS FOUR TIMES, A SUBARACHNOID HEMORRHAGE (SAH) DEVELOPED AT THE BIFURCATION BETWEEN THE M1 AND M2 SEGMENTS. THE PHYSICIAN INFLATED THIS BALLOON IN THE DISSECTED SECTION PORTION OF THE VESSEL FOR APPROX 10 MINS. HEPARIN WAS THEN STOPPED AND THE BALLOON DEFLATED. ANGIOGRAPHY WAS PERFORMED AGAIN AND CONFIRMED THAT THE HEMORRHAGE HAD STOPPED. THE PROCEDURE WAS COMPLETED. THE PATIENT WAS REPORTED TO HAVE "SLIGHT HEMIPLEGIA". THE PHYSICIAN THOUGHT THAT THIS EVENT WAS NOT RELATED TO THIS PRODUCT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GATEWAY PTA DILATATION CATHETER (GBA) CATHETER, BALLOON TYPE LIT BOSTON SCIENTIFIC CORP. 20720-0925 7937100

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention HYPERFORM BALLOON CATHETER| (6) MICRUS ULTIPAQ COILS| 7F LAUNCHER STR 90CM GUIDING CATHETER