BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENUMBRA SYSTEM 5MAX ACE REPERFUSION CATHETER

    MDR report key: 4873026 · Received June 26, 2015

    Report

    Report Number
    3005168196-2015-00630
    Event Type
    Malfunction
    Date Received
    June 26, 2015
    Date of Event
    May 28, 2015
    Report Date
    May 28, 2015
    Manufacturer
    PENUMBRA, INC.
    Product Code
    NRY
    PMA / PMN Number
    K133317
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CORRECTION: K133317.

    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. THIS MDR IS ASSOCIATED WITH MDR (B)(4). NOT RETURNED FROM THE HOSPITAL.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCLUSION: THE PRODUCT LOT NUMBER WAS NOT PROVIDED, THEREFORE, THE MANUFACTURING RECORDS COULD NOT BE REVIEWED.

    Description of Event or Problem · 1

    THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE USING A PENUMBRA SYSTEM 3MAX REPERFUSION CATHETER AND A PENUMBRA SYSTEM 5MAX ACE REPERFUSION CATHETER. UPON REMOVAL FROM THE PACKAGING, A 3MAX CATHETER WAS FOUND FRACTURED AND WAS NOT USED. THE PROCEDURE CONTINUED USING ANOTHER MANUFACTURER'S CATHETER. THE PHYSICIAN ATTEMPTED TO ADVANCE A 5MAX ACE CATHETER OVER THE CATHETER; HOWEVER, IT WAS UNSUCCESSFUL. THE PROCEDURE CONTINUED SUCCESSFULLY USING ANOTHER MANUFACTURER'S DEVICE. THERE WAS NO REPORT OF AN ADVERSE EFFECT ON THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    415206 PENUMBRA SYSTEM 5MAX ACE REPERFUSION CATHETER NRY NRY PENUMBRA, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1