BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    8F BGC 95CM

    MDR report key: 3589236 · Received January 23, 2014

    Report

    Report Number
    0002954917-2014-00001
    Event Type
    Malfunction
    Date Received
    January 23, 2014
    Date of Event
    September 24, 2013
    Report Date
    September 25, 2013
    Manufacturer
    CONCENTRIC MEDICAL
    Product Code
    DQY
    PMA / PMN Number
    K112404
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4)

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORD REVIEW CONFIRMS THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. DEVICE ANALYSIS REVEALED A PIN HOLE LEAK ON THE BALLOON MICROCATHETER SHAFT AT APPROXIMATELY 80CM FROM THE HUB. NO ANOMALIES WERE OBSERVED TO THE MICROCATHETER HUB OR BALLOON. DURING FUNCTIONAL TESTING, FLUID EXITED THE MICROCATHETER SHAFT AT THE SITE OF THE LEAK AND THE BALLOON SLOWLY DEFLATED AS A RESULT. BASED ON THE INFORMATION AVAILABLE, IT IS PROBABLE THAT THE DEVICE BECAME DAMAGED DURING USE, RESULTING IN THE OBSERVED FINDING. THEREFORE A ROOT CAUSE OF OPERATIONAL CONTEXT HAS BEEN ASSIGNED TO THIS INVESTIGATION.

    Description of Event or Problem · 1

    DURING DEVICE ANALYSIS A LEAK WAS NOTED TO THE BALLOON CATHETER SHAFT. THERE WERE NO CLINICAL CONSEQUENCES TO THE PATIENT.

    Description of Event or Problem · 1

    DURING DEVICE ANALYSIS A LEAK WAS NOTED TO THE BALLOON CATHETER SHAFT. THERE WERE NO CLINICAL CONSEQUENCES TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    54369 8F BGC 95CM CATHETER, PERCUTANEOUS DQY CONCENTRIC MEDICAL 36278

    Patients

    Seq Age Sex Outcome Treatment
    1