BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    8F BGC 95CM

    MDR report key: 6122974 · Received November 22, 2016

    Report

    Report Number
    0002954917-2016-00167
    Event Type
    Malfunction
    Date Received
    November 22, 2016
    Date of Event
    November 1, 2016
    Report Date
    January 30, 2017
    Manufacturer
    CONCENTRIC MEDICAL
    Product Code
    DQY
    PMA / PMN Number
    K112404
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORD REVIEW CONFIRMS THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE SUBJECT DEVICE IS NOT AVAILABLE; THEREFORE, FUNCTIONAL TESTING AS WELL AS PHYSICAL ANALYSIS CANNOT BE PERFORMED. THE CAUSE OF THE REPORTED ISSUE COULD NOT BE DEFINITIVELY DETERMINED.

    Additional Manufacturer Narrative · 1

    THE DEVICE IS NOT AVAILABLE TO THE MANUFACTURER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PHYSICIAN HAD DIFFICULTY DEFLATING THE BALLOON DURING PREPARATION. THERE WAS NO PATIENT INVOLVEMENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PHYSICIAN HAD DIFFICULTLY DEFLATING THE BALLOON DURING PREPARATION. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    772283 8F BGC 95CM CATHETER, PERCUTANEOUS DQY CONCENTRIC MEDICAL 60203

    Patients

    Seq Age Sex Outcome Treatment
    1