BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEURON MAX 6F 088 LONG SHEATH

    MDR report key: 5780704 · Received July 9, 2016

    Report

    Report Number
    3005168196-2016-00963
    Event Type
    Injury
    Date Received
    July 9, 2016
    Date of Event
    June 9, 2016
    Report Date
    June 10, 2016
    Manufacturer
    PENUMBRA, INC.
    Product Code
    DQY
    UDI-DI
    00814548012209
    PMA / PMN Number
    K111380
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE PRODUCT WAS NOT RETURNED FOR EVALUATION. WITHOUT THE RETURN OF THE DEVICE, THE ROOT CAUSE OF THE PROBLEM CANNOT BE DETERMINED. THE MANUFACTURING RECORDS FOR THIS LOT WERE REVIEWED AND DID NOT REVEAL ANY OUTSTANDING DISCREPANCIES, DESIGN, OR QUALITY CONCERNS. THIS REPORT IS ASSOCIATED WITH MFR REPORT NUMBER: 3005168196-2016-00964. THE HOSPITAL DISPOSED OF THE DEVICE.

    Description of Event or Problem · 1

    THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE USING A PENUMBRA SYSTEM ACE 64 KIT AND A NEURON MAX 6F 088 LONG SHEATH (NEURON MAX). DURING PREPARATION FOR THE PROCEDURE, AFTER REMOVING THE PENUMBRA SYSTEM ACE 64 REPERFUSION CATHETER (ACE 64) FROM ITS PACKAGING, THE HOSPITAL STAFF NOTICED THAT THE ACE64 WAS UNRAVELED. THE UNRAVELED ACE 64 WAS FOUND PRIOR TO USE AND THEREFORE, WAS NOT USED FOR THE PROCEDURE. A NEW ACE 64 WAS THEN OPENED FOR THE PROCEDURE. DURING THE PROCEDURE, THE PHYSICIAN INITIALLY ATTEMPTED TO USE A NINETY CENTIMETER NEURON MAX FOR A GROIN ACCESS; HOWEVER, THE NEURON MAX WAS REMOVED FROM THE PATIENT DUE TO TORTUOSITY. THERE WAS NO REPORTED DEFICIENCY WITH THIS NEURON MAX. THE PHYSICIAN THEN OPENED AND USED AN EIGHTY CENTIMETER NEURON MAX FOR THE PROCEDURE. HOWEVER, AFTER COMPLETING THE PROCEDURE, WHILE THE PHYSICIAN WAS ATTEMPTING TO REMOVE THE NEURON MAX FROM THE PATIENT, THE PATIENT EXPERIENCED A LOT OF VASOSPASM. SUBSEQUENTLY, THE PHYSICIAN HAD DIFFICULTY REMOVING THE NEURON MAX AND IT BECAME STUCK IN THE RADIAL ARTERY OF THE PATIENT'S ARM. THE PHYSICIAN PULLED ON THE NEURON MAX BUT IT BROKE INSIDE THE PATIENT'S ARM. THEREFORE, THE PHYSICIAN REQUIRED A SNARE DEVICE TO SUCCESSFULLY REMOVE THE BROKEN PIECES FROM THE PATIENT'S ARM AND THEN USED ANOTHER MANUFACTURER'S COILS TO SHUT DOWN PART OF THE RADIAL ARTERY. AS OF (B)(6) 2016, THE PATIENT WAS DOING FINE AND HAD FULL USE OF THE ARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    434717 NEURON MAX 6F 088 LONG SHEATH DQY DQY PENUMBRA, INC. F66386 00814548012209

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| O| R