BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    8F BGC 80CM

    MDR report key: 3049491 · Received April 10, 2013

    Report

    Report Number
    0002954917-2013-00042
    Event Type
    Malfunction
    Date Received
    April 10, 2013
    Date of Event
    March 24, 2013
    Report Date
    March 25, 2013
    Manufacturer
    CONCENTRIC MEDICAL
    Product Code
    DQY
    PMA / PMN Number
    K102657
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORD REVIEW CONFIRMS THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. AS THE DEVICE WAS NOT RETURNED, NO PHYSICAL OR VISUAL ANALYSIS OF THE PRODUCT COULD BE PERFORMED. REVIEW AND ANALYSIS OF ALL AVAILABLE INFORMATION FAILED TO IDENTIFY A DEFINITIVE ASSIGNABLE CAUSE FOR THE REPORTED EVENT. THEREFORE, A PROBABLE CAUSE OF UNDETERMINABLE HAS BEEN ASSIGNED TO THE REPORTED EVENT. THE DEVICE IS NOT AVAILABLE TO THE MANUFACTURER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING PREPARATION FOLLOWING MULTIPLE ASPIRATION ATTEMPTS AIR BUBBLES WERE NOTED COMING FROM THE BALLOON INDICATIVE OF A LEAK. THE PROCEDURE WAS COMPLETED USING ANOTHER OF THE SAME DEVICE. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    148685 8F BGC 80CM CATHETER, PERCUTANEOUS DQY CONCENTRIC MEDICAL 36024

    Patients

    Seq Age Sex Outcome Treatment
    1