BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GATEWAY BALLOON CATHETER

    MDR report key: 2002104 · Received February 28, 2011

    Report

    Report Number
    2939204-2011-00096
    Event Type
    Injury
    Date Received
    February 28, 2011
    Report Date
    February 16, 2011
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    GBA
    PMA / PMN Number
    H050001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSION: ANTICIPATED PROCEDURAL COMPLICATION. THE SUBJECT DEVICE IS NOT AVAILABLE; THEREFORE, PHYSICAL ANALYSIS CANNOT BE PERFORMED. BASED ON THE INFORMATION AVAILABLE, THERE IS NO INDICATION THAT THE DEVICE MALFUNCTIONED OR FAILED TO PERFORM TO SPECIFICATION. STROKE AND HEMORRHAGE ARE KNOWN COMPLICATIONS ASSOCIATED WITH THESE TYPES OF PROCEDURES AND LISTED AS SUCH IN THE DIRECTION FOR USE (DFU). THEREFORE, A ROOT CAUSE OF ANTICIPATED PROCEDURAL COMPLICATION HAS BEEN ASSIGNED TO THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED IN AN ARTICLE IN NEUROSURGERY THAT THE PATIENT UNDERWENT THROMBOLYSIS AND BALLOON ANGIOPLASTY OF THE MIDDLE CEREBRAL ARTERY (MCA) M1 SEGMENT THAT RESULTED IN PARTIAL RECANALIZATION. POST PROCEDURE THE PATIENT SUFFERED A HEMORRHAGIC INFARCTION. IT WAS REPORTED THAT THE PATIENT WAS DISCHARGED WITH SLIGHT DISABILITY. NO OTHER INFORMATION IS AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED IN AN ARTICLE IN NEUROSURGERY THAT THE PATIENT UNDERWENT THROMBOLYSIS AND BALLOON ANGIOPLASTY OF THE MIDDLE CEREBRAL ARTERY (MCA) M1 SEGMENT THAT RESULTED IN PARTIAL RECANALIZATION. POST PROCEDURE THE PATIENT SUFFERED A HEMORRHAGIC INFARCTION WITH SMALL PETECHIAE WITHIN THE INFARCTED AREA. IT WAS REPORTED THAT THE PATIENT WAS DISCHARGED WITH SLIGHT DISABILITY. NO OTHER INFORMATION IS AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED IN AN ARTICLE IN NEUROSURGERY THAT THE PATIENT UNDERWENT THROMBOLYSIS AND BALLOON ANGIOPLASTY OF THE MIDDLE CEREBRAL ARTERY (MCA) M1 SEGMENT THAT RESULTED IN PARTIAL RECANALIZATION. POST PROCEDURE THE PATIENT SUFFERED A HEMORRHAGIC INFARCTION. IT WAS REPORTED THAT THE PATIENT WAS DISCHARGED WITH SLIGHT DISABILITY. NO OTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GATEWAY BALLOON CATHETER CATHETER, BALLOON TYPE GBA BOSTON SCIENTIFIC - MAPLE GROVE UNK574

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Other| S UROKINASE 180000 U| TRANSEND GUIDEWIRE (BOSTON SCIENTIFIC)