BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GATEWAY BALLOON CATHETER

    MDR report key: 1699924 · Received May 26, 2010

    Report

    Report Number
    2939204-2010-00718
    Event Type
    Injury
    Date Received
    May 26, 2010
    Report Date
    May 12, 2010
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    GBA
    PMA / PMN Number
    H050001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSION: .ANTICIPATED PROCEDURAL COMPLICATION. THE DEVICE WAS NOT AVAILABLE FOR EVALUATION. FROM THE INFORMATION PROVIDED THERE IS NO INDICATION THAT THERE WAS ANY DEVICE MALFUNCTION, NONCONFORMANCE OR MISUSE THAT CONTRIBUTED TO THE REPORTED EVENT. VESSEL DISSECTION IS A KNOWN AND ANTICIPATED COMPLICATION TO THESE TYPES OF PROCEDURES AND IS LISTED AS SUCH IN THE DIRECTIONS FOR USE. THEREFORE IT WAS DETERMINED THAT THE REPORTED EVENT WAS AN ANTICIPATED PROCEDURAL COMPLICATION.

    Additional Manufacturer Narrative · 1

    EVENT DATE: THE EXACT DATE WAS NOT PROVIDED, ALL THE PATIENTS IN THE ARTICLE WERE TREATED BETWEEN 2004 AND 2008.COMPLAINT SOURCE - LITERATURE: DASHTI ET AL. NEUROSURGERY 2010; 66(4):825-31. (B) (4).

    Description of Event or Problem · 1

    IT WAS REPORTED IN AN ARTICLE IN NEUROSURGERY THAT THE PATIENT SUFFERED A PERI PROCEDURAL BASILAR ARTERY DISSECTION. THERE WAS NO REPORTED CLINICAL CONSEQUENCE TO THE PATIENT, THE PATIENT OUTCOME AFTER THE PROCEDURE WAS NOTED AS UNCHANGED COMPARED TO PRE PROCEDURE. NO OTHER INFORMATION WAS PROVIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED IN AN ARTICLE IN NEUROSURGERY THAT THE PATIENT SUFFERED A PERI PROCEDURAL BASILAR ARTERY DISSECTION. THERE WAS NO REPORTED CLINICAL CONSEQUENCE TO THE PATIENT, THE PATIENT OUTCOME AFTER THE PROCEDURE WAS NOTED AS UNCHANGED COMPARED TO PRE PROCEDURE. NO OTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GATEWAY BALLOON CATHETER CATHETER, BALLOON TYPE GBA BOSTON SCIENTIFIC - MAPLE GROVE UNK533

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Other WINGSPAN STENT (BOSTON SCIENTIFIC)