BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENUMBRA SYSTEM 5MAX ACE REPERFUSION CATHETER

    MDR report key: 4828694 · Received June 9, 2015

    Report

    Report Number
    3005168196-2015-00569
    Event Type
    Malfunction
    Date Received
    June 9, 2015
    Date of Event
    April 22, 2015
    Report Date
    May 10, 2015
    Manufacturer
    PENUMBRA, INC.
    Product Code
    NRY
    PMA / PMN Number
    K133317
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CORRECTION: K133317.

    Additional Manufacturer Narrative · 1

    (B)(4)

    Additional Manufacturer Narrative · 1

    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. THE HOSPITAL DISCARDED THE DEVICE.

    Description of Event or Problem · 1

    THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE M1 SECTION OF THE INTERNAL CAROTID ARTERY USING A PENUMBRA SYSTEM 5MAX ACE REPERFUSION CATHETER. DURING THE PROCEDURE, THE PHYSICIAN ATTEMPTED TO USE SYRINGE ASPIRATION ON THE ACE CATHETER; HOWEVER, THE PHYSICIAN WAS UNABLE TO ASPIRATE THE THROMBUS. THE PHYSICIAN ATTEMPTED UNSUCCESSFULLY TO ASPIRATE THREE MORE TIMES USING A SYRINGE. THE ACE CATHETER WAS REMOVED AND FOUND TO BE FRACTURED NEAR THE DISTAL TIP. THE PROCEDURE SUCCESSFULLY CONTINUED USING PERCUTANEOUS TRANSLUMINAR ANGIOPLASTY. THERE WAS NO REPORT OF AN ADVERSE EFFECT ON THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    372059 PENUMBRA SYSTEM 5MAX ACE REPERFUSION CATHETER NRY NRY PENUMBRA, INC. F46866

    Patients

    Seq Age Sex Outcome Treatment
    1