BEUDAMED
    FDA Adverse Event Injury Summary report: N

    8F BGC 95CM

    MDR report key: 2915814 · Received January 15, 2013

    Report

    Report Number
    0002954917-2013-00003
    Event Type
    Injury
    Date Received
    January 15, 2013
    Date of Event
    November 17, 2012
    Report Date
    December 21, 2012
    Manufacturer
    CONCENTRIC MEDICAL
    Product Code
    DQY
    PMA / PMN Number
    K102657
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS NOT AVAILABLE TO THE MANUFACTURER.

    Additional Manufacturer Narrative · 1

    CONCLUSION: FOR ANTICIPATED PROCEDURAL COMPLICATION AND CAUSED BY INADEQUATE SETUP/PREPARATION THE DEVICE WAS NOT AVAILABLE FOR ANALYSIS. FROM THE INFORMATION PROVIDED 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. HEMORRHAGE IS A KNOWN AND ANTICIPATED COMPLICATION TO THESE TYPES OF PROCEDURES AND IS NOTED IN THE LABELING. THEREFORE, IT WAS DETERMINED THAT THE REPORTED HEMORRHAGE WAS AN ANTICIPATED PROCEDURAL COMPLICATION. IT WAS REPORTED THAT THE AIR EMBOLISM OCCURRED WHEN THE COAXIAL CATHETER WAS BEING REMOVED FROM THE BALLOON GUIDE CATHETER (BGC). THE AIR EMBOLISM WAS MOST LIKELY CAUSED BY INADEQUATE DEVICE SET UP OR PREPARATION, EITHER OF WHICH ALLOWED AIR INTO THE DEVICE DURING THE REMOVAL OF THE COAXIAL CATHETER FROM THE BGC. THEREFORE, A PROBABLE CAUSE OF CAUSED BY INADEQUATE SETUP/PREPARATION WAS ASSIGNED TO THE REPORTED AIR EMBOLISM.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PHYSICIAN SUCCESSFULLY PERFORMED TWO PASSES WITH THE RETRIEVAL DEVICE TO TREAT A LEFT INTERNAL CAROTID ARTERY (L-ICA) OCCLUSION. THE PATIENT HAD A THROMBOLYSIS IN CEREBRAL ISCHEMIA (TICI) SCORE OF 2A AFTER TREATMENT. HOWEVER, AIR EMBOLISM OCCURRED WHILE THE PHYSICIAN WAS REMOVING THE BALLOON GUIDE CATHETER (SUBJECT DEVICE). POST PROCEDURE, A HEMORRHAGE WAS CONFIRMED AND A CEREBRAL DECOMPRESSION WAS PERFORMED TO RELIEVE INTRACRANIAL PRESSURE. THE PHYSICIAN STATED THAT THE CAUSE OF HEMORRHAGE WAS POSSIBLY RELATED TO A REPERFUSION INJURY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PHYSICIAN SUCCESSFULLY PERFORMED TWO PASSES WITH THE RETRIEVAL DEVICE TO TREAT A LEFT INTERNAL CAROTID ARTERY (L-ICA) OCCLUSION. THE PATIENT HAD A THROMBOLYSIS IN CEREBRAL ISCHEMIA (TICI) SCORE OF 2A AFTER TREATMENT. HOWEVER, AIR EMBOLISM OCCURRED WHILE THE PHYSICIAN WAS REMOVING THE BALLOON GUIDE CATHETER (SUBJECT DEVICE). POST PROCEDURE, A HEMORRHAGE WAS CONFIRMED AND A CEREBRAL DECOMPRESSION WAS PERFORMED TO RELIEVE INTRACRANIAL PRESSURE. THE PHYSICIAN STATED THAT THE CAUSE OF HEMORRHAGE WAS POSSIBLY RELATED TO A REPERFUSION INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    22373 8F BGC 95CM CATHETER, PERCUTANEOUS DQY CONCENTRIC MEDICAL

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention MERCI RETRIEVER ( CONCENTRIC)