BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INDIGO SYSTEM LIGHTNING 12

    MDR report key: 11040292 · Received December 18, 2020

    Report

    Report Number
    3005168196-2020-02299
    Event Type
    Malfunction
    Date Received
    December 18, 2020
    Date of Event
    November 23, 2020
    Report Date
    November 23, 2020
    Manufacturer
    PENUMBRA, INC.
    Product Code
    QEW
    UDI-DI
    00815948022560
    PMA / PMN Number
    K192981
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THE MANUFACTURING RECORDS FOR THIS LOT WERE REVIEWED AND DID NOT REVEAL ANY OUTSTANDING DISCREPANCIES, DESIGN, OR QUALITY CONCERNS. PLEASE NOTE THAT THE FOLLOWING SECTIONS WERE INADVERTENTLY MISSED ON THE INITIAL MFR REPORT AND ARE BEING INCLUDED ON THIS FOLLOW-UP #01 MFR REPORT:3005168196-2020-02299. 1. SECTION D. BOX 10. DEVICE AVAILABLE FOR EVALUATION? 2. SECTION H. BOX 3. DEVICE RETURNED TO MANUFACTURER? 3. SECTION H. BOX 6. METHOD CODES. 4. SECTION H. BOX 6. RESULTS CODES. 5. SECTION H. BOX 6. CONCLUSIONS CODES.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE USING AN INDIGO SYSTEM ASPIRATION CATHETER 12 (CAT12), A NON-PENUMBRA SHEATH AND A GUIDEWIRE. DURING THE PROCEDURE, THE PHYSICIAN PLACED THE SHEATH INTO THE RIGHT INTERNAL JUGULAR (IJ) VEIN AND ACCESSED TRANSJUGULAR INTRAHEPATIC PORTOSYSTEMIC SHUNT (TIPS). AFTERWARDS, THE PHYSICIAN ADVANCED THE CAT12 OVER THE GUIDEWIRE INTO THE PORTAL VEIN AND THEN THE GUIDEWIRE WAS REMOVED. THEN, THE PHYSICIAN ATTEMPTED TO ADVANCE THE TIP OF THE CAT12 INTO THE CLOT; HOWEVER, THE PHYSICIAN WAS UNABLE TO ENGAGE THE CLOT WITH THE CAT12. THEREFORE, THE CAT12 WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW CAT12 AND THE SAME SHEATH. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1503488 INDIGO SYSTEM LIGHTNING 12 QEW QEW PENUMBRA, INC. LITNG12XTORQ100-A F100354 00815948022560

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR