BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENUMBRA SYSTEM ACE 64 REPERFUSION CATHETER

    MDR report key: 5411661 · Received February 4, 2016

    Report

    Report Number
    3005168196-2016-00121
    Event Type
    Malfunction
    Date Received
    February 4, 2016
    Date of Event
    January 1, 2016
    Report Date
    January 6, 2016
    Manufacturer
    PENUMBRA, INC.
    Product Code
    NRY
    UDI-DI
    00814548016207
    PMA / PMN Number
    K142458
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    RESULT: UPON FIRST EVALUATION OF THE RETURNED PENUMBRA SYSTEM ACE 64 REPERFUSION CATHETER (ACE 64), THE STRAIN RELIEF WAS OFFSET. THE STRAIN RELIEF WAS PARTIALLY UNWOUND BY A PENUMBRA INVESTIGATOR TO REVEAL THE ACE 64 WAS FRACTURED UNDER THE STRAIN RELIEF APPROXIMATELY 1.0 CM FROM THE HUB. CONCLUSION: EVALUATION OF THE RETURNED DEVICE REVEALED IT WAS FRACTURED UNDER THE STRAIN RELIEF. THIS TYPE OF DAMAGE TYPICALLY OCCURS DUE TO FORCEFUL MANIPULATION AT EXTREME ANGLES DURING PREPARATION OR USE. THE FRACTURE UNDER THE STRAIN RELIEF LIKELY CAUSED THE LEAKING THAT WAS REPORTED IN THE COMPLAINT. PENUMBRA CATHETERS ARE 100% VISUALLY INSPECTED DURING IN-PROCESS INSPECTION. THE MANUFACTURING RECORDS FOR THIS LOT WERE REVIEWED AND DID NOT REVEAL ANY OUTSTANDING DISCREPANCIES, DESIGN, OR QUALITY CONCERNS.

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS AVAILABLE FOR RETURN. A FOLLOW UP MDR WILL BE SUBMITTED UPON COMPLETION OF THE DEVICE INVESTIGATION.

    Additional Manufacturer Narrative · 1

    510(K): K142458.

    Description of Event or Problem · 1

    THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE USING A PENUMBRA SYSTEM ACE 64 REPERFUSION CATHETER (ACE 64). DURING THE MIDDLE OF PROCEDURE, THE TECHNOLOGIST HEARD AIR AND THEN NOTICED THAT THERE WAS A LEAK AT THE HUB OF THE ACE 64. THE ACE 64 WAS REMOVED FROM THE PATIENT AND THE PROCEDURE WAS COMPLETED USING A NEW ACE 64. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    68005 PENUMBRA SYSTEM ACE 64 REPERFUSION CATHETER NRY NRY PENUMBRA, INC. F65468 00814548016207

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR