BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENUMBRA SYSTEM JET7 REPERFUSION CATHETER

    MDR report key: 10462577 · Received August 27, 2020

    Report

    Report Number
    3005168196-2020-01295
    Event Type
    Malfunction
    Date Received
    August 27, 2020
    Date of Event
    June 30, 2020
    Report Date
    August 4, 2020
    Manufacturer
    PENUMBRA, INC.
    Product Code
    NRY
    UDI-DI
    00815948020955
    PMA / PMN Number
    K190010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    PLEASE NOTE THAT THE FOLLOWING SECTION WAS INCORRECTLY REPORTED ON THE INITIAL MFR REPORT AND IS BEING CORRECTED ON THIS FOLLOW-UP #01 MFR REPORT:3005168196-2020-012951. SECTION B. BOX 3. DATE OF EVENT H3 OTHER TEXT : PLACEHOLDER

    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.

    Description of Event or Problem · 1

    THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE RIGHT M1 SEGMENT OF THE MIDDLE CEREBRAL ARTERY (MCA) USING A NEURON MAX 6F 088 LONG SHEATH (NEURON MAX), PENUMBRA SYSTEM JET 7 REPERFUSION CATHETER (JET7), AND PENUMBRA SYSTEM 3MAX REPERFUSION CATHETER (3MAXC). DURING THE PROCEDURE, THE PHYSICIAN ADVANCED THE JET7 OVER THE 3MAXC AND THROUGH THE NEURON MAX TO THE TARGET VESSEL. THE PHYSICIAN THEN COMPLETED THREE PASSES USING THE JET7. AFTER THE THIRD PASS, THE JET7 WAS REMOVED AND FLUSHED ON THE BACK TABLE. AFTER FLUSHING, THE PHYSICIAN NOTICED THAT THE DISTAL TIP OF THE JET7 EXPANDED AND; THEREFORE, THE JET7 WAS NOT USED FOR THE REMAINDER OF THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING A NON-PENUMBRA STENT RETRIEVER WITH THE SAME NEURON MAX AND 3MAXC. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    926040 PENUMBRA SYSTEM JET7 REPERFUSION CATHETER NRY NRY PENUMBRA, INC. 5MAXJET7-B F93838 00815948020955

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR