BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEURON 6F SELECT CATHETER

    MDR report key: 4200757 · Received October 24, 2014

    Report

    Report Number
    3005168196-2014-00759
    Event Type
    Injury
    Date Received
    October 24, 2014
    Date of Event
    October 6, 2014
    Report Date
    October 7, 2014
    Manufacturer
    PENUMBRA, INC.
    Product Code
    DQY
    PMA / PMN Number
    K083125
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSION: THE PRODUCT WAS NOT RETURNED FOR EVALUATION. WITHOUT THE RETURN OF THE DEVICE, THE ROOT CAUSE OF THE PROBLEM CANNOT BE DETERMINED. IMAGES WERE PROVIDED TO THE MANUFACTURER; HOWEVER, AFTER FURTHER REVIEW BY A MEDICAL PROFESSIONAL, THE MANUFACTURER WAS UNABLE TO DETERMINE WHAT THE FOREIGN BODY WAS. THE MATERIALS IN THE CATHETERS INCLUDE COATING, POLYMERS, AND METALS. NEITHER THE COATING OR POLYMERS WOULD SHOW UP ON FLUOROSCOPY. THE METALS THE MANUFACTURER USES ARE PLATINUM, NITINOL, AND STAINLESS STEEL. NEITHER NITINOL OR STAINLESS STEEL ARE VISIBLE UNDER FLUOROSCOPY. THE PLATINUM USED, IS A LARGE SOLID MARKER BAND, MUCH LARGER THAN WHAT IS OBSERVED. ALSO, A LARGE MARKER WOULD BE VISIBLE ON A COMPUTED TOMOGRAPHY (CT); HOWEVER, THE CT PROVIDED WAS CLEAR. THIS MDR IS ASSOCIATED WITH MDR 3005168196-2014-00755, 00756, 00757, AND 00758. DEVICE WAS DISPOSED OF BY THE HOSPITAL.

    Description of Event or Problem · 1

    THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE MIDDLE CEREBRAL ARTERY (MCA) USING A NEURON MAX, A NEURON 6F SELECT CATHETER, A PENUMBRA SYSTEM 3MAX REPERFUSION CATHETER, AND A PENUMBRA SYSTEM 5MAX ACE REPERFUSION CATHETER OVER A NON-PENUMBRA GUIDE WIRE. DURING THE PROCEDURE, THE PHYSICIAN WAS ABLE TO SUCCESSFULLY REMOVE THROMBUS. FOLLOWING THE PROCEDURE, A MAGNETIC RESONANCE IMAGING (MRI) REVEALED AN ARTIFACT IN THE MCA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    680185 NEURON 6F SELECT CATHETER DQY DQY PENUMBRA, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Other