BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    8F BGC 80CM

    MDR report key: 3592370 · Received January 26, 2014

    Report

    Report Number
    0002954917-2014-00002
    Event Type
    Malfunction
    Date Received
    January 26, 2014
    Date of Event
    January 1, 2014
    Report Date
    January 14, 2014
    Manufacturer
    CONCENTRIC MEDICAL
    Product Code
    DQY
    PMA / PMN Number
    K112404
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, 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. MICROSCOPE ANALYSIS REVEALED A CRACK ON THE SIDE PORT OF THE HUB. NO OTHER VISUAL ANOMALIES WERE FOUND. DURING PERFORMANCE TESTING A DEMO DILATOR WAS ADVANCED THROUGH THE BALLOON CATHETER SHAFT WITHOUT ISSUES. THE BALLOON WAS ATTEMPTED TO BE INFLATED BUT FLUID LEAKED AT THE HUB. THE BALLOON COULD NOT BE INFLATED DUE TO THE CRACK ON THE HUB. THE BALLOON CATHETER DIMENSIONS WERE FOUND WITHIN SPECIFICATION. INFORMATION AVAILABLE INDICATED THAT THE PACKAGING CONTAINING THE DEVICE WAS CONFIRMED TO BE IN GOOD CONDITION, THE DEVICE APPEARED TO BE IN GOOD CONDITION AFTER UNPACKING AND THAT IT WAS PREPARED AS PER DIRECTIONS FOR USE. BASED ON THE INFORMATION AVAILABLE THE ROOT CAUSE FOR THE DAMAGE FOUND ON HUB CANNOT BE DETERMINED. THE MANUFACTURER HAS REVIEWED ALL INFORMATION AND DETERMINED THIS EVENT NO LONGER MEETS THE REQUIREMENT OF THE REPORTABLE EVENT FOR THE DEVICE IN QUESTION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING PREPARATION AIR BUBBLES WERE OBSERVED IN THE BALLOON GUIDE CATHETER. THERE WAS NO PATIENT INVOLVEMENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING PREPARATION AIR BUBBLES WERE OBSERVED IN THE BALLOON GUIDE CATHETER. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    58192 8F BGC 80CM CATHETER, PERCUTANEOUS DQY CONCENTRIC MEDICAL 36104

    Patients

    Seq Age Sex Outcome Treatment
    1