BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    8F BGC 95CM

    MDR report key: 2889113 · Received December 28, 2012

    Report

    Report Number
    0002954917-2012-00141
    Event Type
    Malfunction
    Date Received
    December 28, 2012
    Date of Event
    December 12, 2012
    Report Date
    December 14, 2012
    Manufacturer
    CONCENTRIC MEDICAL
    Product Code
    DQY
    PMA / PMN Number
    K102657
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER.

    Additional Manufacturer Narrative · 1

    CORRECTION: PRODUCT AVAILABLE TO STRYKER - CORRECTED. THE DEVICE HISTORY RECORD REVIEW CONFIRMS THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. VISUAL INSPECTION OF THE RETURNED DEVICE DID NOT FIND ANY ANOMALIES. DURING THE PERFORMANCE TEST, THE BALLOON WAS SUCCESSFULLY INFLATED WITH BOTH AIR AND WATER AND THERE WERE NO AIR BUBBLES NOTED DIFFUSING FROM THE BALLOON. FURTHER INVESTIGATION USING A VACUUM WAS PERFORMED TO CHECK FOR LEAKS IN THE LUMEN AND THE HUB AND THERE WERE NO AIR BUBBLES SEEN COMING FROM THE BALLOON LUMEN OR THE GUIDEWIRE LUMEN INTO THE HUB AND INTO THE SYRINGE. THE DEVICE FUNCTIONED AS INTENDED. THEREFORE, A PROBABLE ASSIGNABLE CAUSE OF NOT CONFIRMED HAS BEEN SELECTED FOR THE REPORTED EVENT. 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 FOLLOWING MULTIPLE ASPIRATION ATTEMPTS, THE BALLOON WAS INFLATED. WHILE THE BALLOON WAS INFLATED AIR BUBBLES NOTED COMING FROM THE BALLOON INDICATIVE OF A LEAK. THE PHYSICIAN SUSPECTED THAT THERE APPEARED TO BE A COMMUNICATION (OR A HOLE) BETWEEN THE BALLOON LUMEN AND THE GUIDEWIRE LUMEN. THE PROCEDURE WAS COMPLETED USING ANOTHER OF THE SAME DEVICE. THERE WAS NO PATIENT INVOLVEMENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING PREPARATION FOLLOWING MULTIPLE ASPIRATION ATTEMPTS, THE BALLOON WAS INFLATED. WHILE THE BALLOON WAS INFLATED AIR BUBBLES NOTED COMING FROM THE BALLOON INDICATIVE OF A LEAK. THE PHYSICIAN SUSPECTED THAT THERE APPEARED TO BE A COMMUNICATION (OR A HOLE) BETWEEN THE BALLOON LUMEN AND THE GUIDEWIRE LUMEN. 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
    1 8F BGC 95CM CATHETER, PERCUTANEOUS DQY CONCENTRIC MEDICAL 35903

    Patients

    Seq Age Sex Outcome Treatment
    1