BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENUMBRA SYSTEM 3MAX REPERFUSION CATHETER

    MDR report key: 6324386 · Received February 10, 2017

    Report

    Report Number
    3005168196-2017-00180
    Event Type
    Malfunction
    Date Received
    February 10, 2017
    Date of Event
    January 8, 2017
    Report Date
    January 13, 2017
    Manufacturer
    PENUMBRA, INC.
    Product Code
    NRY
    UDI-DI
    00814548012490
    PMA / PMN Number
    K160449
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RETURNED AND THE INVESTIGATION RESULTS ARE PENDING. A FOLLOW UP MDR WILL BE SUBMITTED UPON COMPLETION OF THE DEVICE INVESTIGATION.

    Additional Manufacturer Narrative · 1

    RESULTS: THE PENUMBRA SYSTEM 3MAX REPERFUSION CATHETER (3MAX) WAS KINKED IN MULTIPLE LOCATIONS THROUGHOUT ITS LENGTH. THE 3MAX WAS STRETCHED APPROXIMATELY 117.0 CM FROM THE HUB AND FRACTURED APPROXIMATELY 132.0 CM FROM THE HUB. THE SEGMENT OF THE 3MAX DISTAL TO THE FRACTURE WAS STRETCHED. CONCLUSIONS: EVALUATION OF THE RETURNED DEVICE REVEALED THAT IT WAS STRETCHED AND FRACTURED. IT IS POSSIBLE FOR THE DISTAL SEGMENT OF THE 3MAX TO BECOME PINNED OR OTHERWISE RESTRAINED AGAINST OTHER DEVICES OR PATIENT ANATOMY. IF THE 3MAX BECOMES PINNED OR RESTRAINED AND IS THEN FORCEFULLY RETRACTED AGAINST THIS RESISTANCE, THE 3MAX MAY BECOME STRETCHED AND FRACTURED. FURTHER EVALUATION REVEALED THE 3MAX WAS KINKED IN MULTIPLE LOCATIONS. THE KINKS OBSERVED THROUGHOUT THE 3MAX WERE INCIDENTAL AND MAY HAVE OCCURRED DUE TO RETURN PACKAGING CONDITIONS. THE 5MAX ACE MENTIONED IN THE COMPLAINT WAS NOT RETURNED FOR EVALUATION. PENUMBRA CATHETERS ARE INSPECTED DURING IN-PROCESS INSPECTION AND DURING QUALITY INSPECTION AFTER MANUFACTURING. THE MANUFACTURING RECORDS FOR THIS LOT WERE REVIEWED AND DID NOT REVEAL ANY OUTSTANDING DISCREPANCIES, DESIGN, OR QUALITY CONCERNS.

    Description of Event or Problem · 1

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    107153 PENUMBRA SYSTEM 3MAX REPERFUSION CATHETER NRY NRY PENUMBRA, INC. F66950 00814548012490

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR