BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INDIGO SYSTEM LIGHTNING 7

    MDR report key: 11753736 · Received April 30, 2021

    Report

    Report Number
    3005168196-2021-00910
    Event Type
    Malfunction
    Date Received
    April 30, 2021
    Date of Event
    April 2, 2021
    Report Date
    April 2, 2021
    Manufacturer
    PENUMBRA, INC.
    Product Code
    QEW
    UDI-DI
    00815948022584
    PMA / PMN Number
    K193595
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    EVALUATION OF THE RETURNED CAT7 CONFIRMED THAT THE DISTAL SHAFT WAS CURLED UP INTO LOOPS. THE ROOT CAUSE OF THIS DAMAGE COULD NOT BE DETERMINED. FURTHER EVALUATION OF THE DEVICE REVEALED A DISTAL KINK. THIS DAMAGE WAS LIKELY A RESULT OF THE DEVICE GETTING PINNED DURING THE PROCEDURE. FURTHER EVALUATION ALSO REVEALED AN ADDITIONAL KINK NEAR ITS PROXIMAL END. THIS DAMAGE WAS INCIDENTAL TO THE COMPLAINT AND MAY HAVE OCCURRED DURING PACKAGING FOR THE RETURN. 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. SECTION H. BOX 6. CONCLUSIONS CODE 1: 4316 - THE INVESTIGATION FINDINGS DO NOT LEAD TO A CLEAR CONCLUSION ABOUT THE ROOT CAUSE OF DISTAL SHAFT DAMAGE.

    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.

    Description of Event or Problem · 1

    THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE USING AN INDIGO SYSTEM ASPIRATION CATHETER 7 (CAT7), LIGHTNING ASPIRATION TUBING (LIGHTNING), AND A NON-PENUMBRA SHEATH. DURING THE PROCEDURE, THE PHYSICIAN COMPLETED A FEW PASSES USING THE CAT7. SUBSEQUENTLY, UPON COMPLETING ASPIRATION WITH THE CAT7, THE PHYSICIAN EXPERIENCED RESISTANCE WHILE RETRACTING THE CAT7. IT WAS ALSO REPORTED THAT THE PHYSICIAN NOTICED THE CAT7 WAS PINNED AND, CONSEQUENTLY, THE DISTAL ONE THIRD OF THE CAT7 CURLED UP INTO TIGHT LOOPS AFTER REMOVING IT OFF FROM THE GUIDEWIRE.THE THROMBECTOMY PORTION WAS COMPLETED AT THIS POINT. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    653441 INDIGO SYSTEM LIGHTNING 7 QEW QEW PENUMBRA, INC. LITNG7XTORQ130-A F103322 00815948022584

    Patients

    Seq Age Sex Outcome Treatment
    1