BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENUMBRA SYSTEM 4MAX REPERFUSION CATHETER

    MDR report key: 5158056 · Received October 16, 2015

    Report

    Report Number
    3005168196-2015-01067
    Event Type
    Malfunction
    Date Received
    October 16, 2015
    Date of Event
    August 17, 2015
    Report Date
    September 21, 2015
    Manufacturer
    PENUMBRA, INC.
    Product Code
    NRY
    UDI-DI
    00814548012414
    PMA / PMN Number
    K133317
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS: THE PENUMBRA SYSTEM 4MAX REPERFUSION CATHETER (4MAX) WAS FRACTURED APPROXIMATELY 1.0 CM FROM THE HUB. CONCLUSIONS: EVALUATION OF THE RETURNED DEVICE CONFIRMED IT WAS FRACTURED. THIS TYPE OF DAMAGE TYPICALLY OCCURS DUE TO IMPROPER HANDLING DURING USE. IF THE 4MAX IS MANIPULATED FORCEFULLY AT AN ANGLE DURING POSITIONING WITHIN THE PATIENT, DAMAGE SUCH AS THIS MAY OCCUR. THESE DEVICES 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

    CORRECTION TO SECTION: K133317.

    Description of Event or Problem · 1

    THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE USING A PENUMBRA SYSTEM 4MAX REPERFUSION CATHETER (4MAX). DURING THE PROCEDURE, WHILE ADVANCING THE 4MAX THROUGH THE VESSEL, THE PHYSICIAN MET RESISTANCE AND DECIDED TO REPOSITION THE 4MAX. HOWEVER, UPON MANIPULATION OF THE 4MAX, THE HUB SEPARATED INTO TWO PARTS AND WAS SAFELY REMOVED FROM THE PATIENT. THE PROCEDURE CONTINUED USING A NEW 4MAX. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    688161 PENUMBRA SYSTEM 4MAX REPERFUSION CATHETER NRY NRY PENUMBRA, INC. F47348 00814548012414

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR