BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    8F BGC 95CM

    MDR report key: 2948743 · Received February 7, 2013

    Report

    Report Number
    0002954917-2013-00013
    Event Type
    Malfunction
    Date Received
    February 7, 2013
    Date of Event
    January 8, 2013
    Report Date
    January 11, 2013
    Manufacturer
    CONCENTRIC MEDICAL
    Product Code
    DQY
    PMA / PMN Number
    K112404
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN DISPOSED.

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS UPON ITS RELEASE. AS THE DEVICE WAS NOT RETURNED FOR ANALYSIS, A DEFINITIVE ROOT CAUSE CANNOT BE ASSIGNED. SINCE THE REPORTED EVENT OCCURRED DURING THE PROCEDURE, IT APPEARS THAT PROCEDURAL FACTORS LIMITED THE DEVICE PERFORMANCE. THEREFORE, DEVICE DAMAGED DURING USE IS THE MOST LIKELY CAUSE OF THE REPORTED EVENT.

    Description of Event or Problem · 1

    DURING A PROCEDURE THE BALLOON GUIDE CATHETER RUPTURED INSIDE THE CAROTID ARTERY. THE CATHETER WAS SUCCESSFULLY REMOVED AND THE CASE WAS SUCCESSFUL. THERE WAS NO CONSENESCENCES TO THE PATIENT.

    Description of Event or Problem · 1

    DURING A PROCEDURE THE BALLOON GUIDE CATHETER RUPTURED INSIDE THE CAROTID ARTERY. THE CATHETER WAS SUCCESSFULLY REMOVED AND THE CASE WAS SUCCESSFUL. THERE WAS NO CONSENESCENCE TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    52458 8F BGC 95CM CATHETER, PERCUTANEOUS DQY CONCENTRIC MEDICAL 35711

    Patients

    Seq Age Sex Outcome Treatment
    1 BGC (CONCENTRIC)