BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9F BGC 95CM

    MDR report key: 5049426 · Received September 2, 2015

    Report

    Report Number
    0002954917-2015-00078
    Event Type
    Malfunction
    Date Received
    September 2, 2015
    Date of Event
    July 17, 2015
    Report Date
    August 10, 2015
    Manufacturer
    CONCENTRIC MEDICAL
    Product Code
    DQY
    PMA / PMN Number
    K102657
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE SUBJECT DEVICE WAS DISPOSED.

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORD (DHR) REVIEW WAS UNABLE TO BE PERFORMED AS THE REPORTED LOT NUMBER WAS NOT RECOGNIZED BY THE MANUFACTURER. ATTEMPTS WERE MADE TO OBTAIN THE CORRECT LOT NUMBER; HOWEVER NO OTHER NUMBER WAS REPORTED. THE DEVICE WAS NOT RETURNED FOR EVALUATION; THEREFORE, TESTING AND A FUNCTIONAL ANALYSIS COULD NOT BE PERFORMED. BASED ON THE INFORMATION CURRENTLY AVAILABLE THE CAUSE OF THE REPORTED ISSUE CANNOT BE DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT PRESENTED WITH M1 LEFT SIDE OCCLUSION. DURING PROCEDURE THE PHYSICIAN ATTEMPTED TO INFLATE THE BALLOON GUIDE CATHETER; HOWEVER, THE BALLOON DID NOT INFLATE. THE PHYSICIAN REMOVED THE BALLOON GUIDE CATHETER AND REPORTED THAT THE BALLOON HAD BURST.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT PRESENTED WITH M1 LEFT SIDE OCCLUSION. DURING PROCEDURE THE PHYSICIAN ATTEMPTED TO INFLATE THE BALLOON GUIDE CATHETER; HOWEVER, THE BALLOON DID NOT INFLATE. THE PHYSICIAN REMOVED THE BALLOON GUIDE CATHETER AND REPORTED THAT THE BALLOON HAD BURST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    580615 9F BGC 95CM CATHETER PERCUTANEOUS DQY CONCENTRIC MEDICAL 4975481

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR