BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLOWGATE 8F X 85 CM

    MDR report key: 3951492 · Received July 22, 2014

    Report

    Report Number
    0002954917-2014-00015
    Event Type
    Malfunction
    Date Received
    July 22, 2014
    Date of Event
    July 1, 2014
    Report Date
    July 7, 2014
    Manufacturer
    CONCENTRIC MEDICAL
    Product Code
    DQY
    PMA / PMN Number
    K131492
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORD REVIEW CONFIRMS THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. ANALYSIS OF THE RETURNED DEVICE REVEALED THAT THE CATHETER SHAFT WAS SEVERELY KINKED AT 3.5 CM, 30 CM, 49.5 CM, 65 CM, AND 73 CM FROM ITS PROXIMAL END. IT WAS ALSO SEVERELY COMPRESSED AT SEVERAL PLACES ALONG ITS LENGTH. THE CATHETER SHAFT WAS EXAMINED ALONG ITS LENGTH AND IT WAS FOUND TO BE DEFORMED, COMPRESSED AND SLIGHTLY WRINKLED ON SEVERAL PLACES ALONG ITS LENGTH. IN ADDITION THE CATHETER SHAFT DISTAL LUMEN WAS COMPRESSED. THE BALLOON WAS EXAMINED UNDER MAGNIFICATION AND IT WAS OBSERVED THAT THE BALLOON WAS FOUND WITH A PERFORATION/HOLE. THE BALLOON BONDS WERE INSPECTED AND FOUND INTACT. MICROSCOPIC INSPECTION OF THE BALLOON REVEALED THAT THE BALLOON WAS SLIGHTLY STRETCHED BACK DISTALLY AND PROXIMALLY. DURING FUNCTIONAL ANALYSIS, ATTEMPTS WERE MADE TO INFLATE THE BALLOON; HOWEVER, THE BALLOON FAILED TO INFLATE DUE TO THE PERFORATION/HOLE THAT WAS NOTED. ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE BALLOON RUPTURED WHEN IT WAS PLACED IN AN AREA OF HIGH PLAQUE DENSITY. BASED ON THE INVESTIGATION AND THE INFORMATION AVAILABLE, IT IS LIKELY THAT ANATOMICAL FACTORS WERE THE MOST LIKELY CAUSE OF THE REPORTED EVENT. THEREFORE, A ROOT CAUSE OF OPERATIONAL CONTEXT HAS BEEN ASSIGNED TO THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BALLOON RUPTURED INSIDE THE PATIENT. THE PHYSICIAN HAD PLACED THE BALLOON IN AN AREA OF HIGH DENSITY PLAQUE IN THE PROXIMAL INTERNAL CAROTID ARTERY WHICH HE BELIEVES MAY HAVE CONTRIBUTED TO THE BALLOON RUPTURE. THERE WERE NO CLINICAL CONSEQUENCES TO THE PATIENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BALLOON RUPTURED INSIDE THE PATIENT. THE PHYSICIAN HAD PLACED THE BALLOON IN AN AREA OF HIGH DENSITY PLAQUE IN THE PROXIMAL INTERNAL CAROTID ARTERY WHICH HE BELIEVES MAY HAVE CONTRIBUTED TO THE BALLON RUPTURE. THERE WERE NO CLINICAL CONSEQUENCES TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    429048 FLOWGATE 8F X 85 CM PERCUTANEOUS CATHETER DQY CONCENTRIC MEDICAL 37259

    Patients

    Seq Age Sex Outcome Treatment
    1