BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    8F BGC 95CM

    MDR report key: 3067170 · Received April 18, 2013

    Report

    Report Number
    0002954917-2013-00054
    Event Type
    Malfunction
    Date Received
    April 18, 2013
    Date of Event
    April 6, 2013
    Report Date
    April 9, 2013
    Manufacturer
    CONCENTRIC MEDICAL
    Product Code
    DQY
    PMA / PMN Number
    K102657
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    VISUAL INSPECTION OF THE RETURNED DEVICE FOUND A KINK ON THE CATHETER SHAFT APPROXIMATELY 70CM FROM HUB AND A PINHOLE AT THE KINK LOCATION. THE BALLOON WAS INFLATED AND A SLOW LEAK FROM THE PINHOLE WAS NOTED. THE DEVICE MEASUREMENTS WERE INSIDE SPECIFICATION. FROM THE INFORMATION PROVIDED AND THE INVESTIGATION RESULTS THE DEVICE PASSED ALL MANUFACTURING AND QUALITY INSPECTIONS; THERE WAS NO ANOMALIES FOUND DURING THE DEVICE PREPARATION AND THERE WAS NO INDICATION THAT THE DEVICE WAS NOT USED AS IN ACCORDANCE WITH THE LABELING OR THAT THIS CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. MOST LIKELY SOME PROCEDURAL FACTORS DURING USE CONTRIBUTED TO THE DEVICE DAMAGE AND PERFORMANCE WAS LIMITED. THEREFORE, AN ASSIGNABLE CAUSE OF DEVICE DAMAGED DURING USE WAS SELECTED FOR THE BALLOON CATHETER SHAFT LEAKED. THE KINK FOUND ON THE CATHETER SHAFT WAS MOST LIKELY RELATED TO THE MANNER THE DEVICE WAS HANDLED DURING THE USE OF THE DEVICE.

    Description of Event or Problem · 1

    THE PATIENT WAS UNDERGOING THROMBOLYSIS AND ANGIOPLASTY USING A RETRIEVER DEVICE AND BALLOON GUIDE CATHETER (SUBJECT DEVICE) TO TREAT AN OCCLUSION IN THE RIGHT MIDDLE CEREBRAL ARTERY. THE PHYSICIAN HAD MADE TWO SUCCESSFULLY PASSES; HOWEVER DURING THE THIRD PASS THE BALLOON GUIDE CATHETER WAS NOTED TO BE LEAKING FROM THE CATHETER SHAFT. THE PROCEDURE WAS STOPPED AND ALL DEVICES WERE REMOVED. THE PATIENT WAS REPORTEDLY STABLE.

    Description of Event or Problem · 1

    THE PATIENT WAS UNDERGOING THROMBOLYSIS AND ANGIOPLASTY USING A RETRIEVER DEVICE AND BALLOON GUIDE CATHETER (SUBJECT DEVICE) TO TREAT AN OCCLUSION IN THE RIGHT MIDDLE CEREBRAL ARTERY. THE PHYSICIAN HAD MADE TWO SUCCESSFULLY PASSES; HOWEVER, DURING THE THIRD PASS THE BALLOON GUIDE CATHETER WAS NOTED TO BE LEAKING FROM THE CATHETER SHAFT. THE PROCEDURE WAS STOPPED AND ALL DEVICES WERE REMOVED. THE PATIENT WAS REPORTEDLY STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    167822 8F BGC 95CM CATHETER, PERCUTANEOUS DQY CONCENTRIC MEDICAL

    Patients

    Seq Age Sex Outcome Treatment
    1 91 YR TREVO PRO VUE (CONCENTRIC)