BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PENUMBRA MICROCATHETER 025 (PX400 MICROCATHETER)

    MDR report key: 2880496 · Received December 19, 2012

    Report

    Report Number
    3005168196-2012-00435
    Event Type
    Injury
    Date Received
    December 19, 2012
    Date of Event
    November 20, 2012
    Report Date
    November 20, 2012
    Manufacturer
    PENUMBRA, INC.
    Product Code
    DQY
    PMA / PMN Number
    K100826
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSION: VESSEL PERFORATION AND HEMORRHAGE ARE KNOWN AND ANTICIPATED COMPLICATIONS WITH THESE TYPES OF PROCEDURES AND ARE NOTED IN THE DEVICE LABELING. THEREFORE, IT WAS DETERMINED THAT THE REPORTED EVENT WAS AN ANTICIPATED PROCEDURAL COMPLICATION. THE MANUFACTURING RECORDS FOR THIS LOT WERE REVIEWED AND DID NOT REVEAL ANY OUTSTANDING DISCREPANCIES, QUALITY, OR DESIGN CONCERNS. DISCARDED BY HOSPITAL.

    Description of Event or Problem · 1

    ON (B)(6) 2012, THE PHYSICIAN PERFORMED COIL-EMBOLIZATION ON THE PATIENT WITH JAILING PERFORMANCE THROUGH THE PCA - BA. THE PHYSICIAN PLACED AN ENTERPRISE STENT 4.5MM X 22MM TO THE LEFT PCA-BA. HE THEN INSERTED THE PX400 CATHETER INTO THE STENT, BUT THE PX400 CATHETER DROPPED DOWN SLIGHTLY. THE PHYSICIAN TRIED TO UP THE PX400 CATHETER WITH CHIKAI 14 WIRE GUIDE SLIGHTLY. WHEN ANGIOGRAPHY WAS PERFORMED, HE CONFIRMED THE LEAKAGE OF THE CONTRAST AGENT OUTSIDE THE ANEURYSM (EXTRAVASATION OF THE BASILAR ARTERY ANEURYSM) (SAH). THEREFORE, LOWERING THE BLOOD PRESSURE OF THE PATIENT, NEUTRALIZE THE HEPARIN AND COIL EMBOLIZATION WITHIN THE ANEURYSM. IT WAS STOPPED BLEEDING AFTER 2 HOURS FROM LEAKAGE. DUE TO VENTRICULAR DRAINAGE AND HEMATOMA REMOVAL, THE PATIENT WAS MIGRATED TO THE OPERATIONS. DOCTOR'S COMMENT : I DO NOT KNOW EITHER OF PX400 MICRO CATHETER OR GUIDE WIRE, IS HOW DID PENETRATE THE WALL OF THE ANEURYSM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PENUMBRA MICROCATHETER 025 (PX400 MICROCATHETER) DQY DQY PENUMBRA, INC. F29122

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention