BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INDIGO SYSTEM LIGHTNING 7

    MDR report key: 11971176 · Received June 9, 2021

    Report

    Report Number
    3005168196-2021-01290
    Event Type
    Injury
    Date Received
    June 9, 2021
    Date of Event
    May 14, 2021
    Report Date
    September 21, 2021
    Manufacturer
    PENUMBRA, INC.
    Product Code
    QEW
    UDI-DI
    00815948022584
    PMA / PMN Number
    K193595
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    EVALUATION OF THE RETURNED CAT7 CONFIRMED A FRACTURE. BASED ON THE DAMAGE AT THE FRACTURE SITE, THIS BREAK WAS LIKELY A RESULT OF TORQUEING AGAINST RESISTANCE. IF THE DEVICE IS TORQUED EXCESSIVELY AGAINST RESISTANCE, DAMAGE SUCH AS A FRACTURE MAY OCCUR. EVALUATION ALSO REVEALED BENDS ON THE DISTAL LENGTH OF THE DEVICE. THIS DAMAGE WAS INCIDENTAL TO THE REPORTED COMPLAINT. 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. H3 OTHER TEXT : PLACEHOLDER.

    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 IN THE SUPERFICIAL FEMORAL ARTERY (SFA) USING AN INDIGO SYSTEM ASPIRATION CATHETER 7 (CAT7), A NON-PENUMBRA SHEATH, AND A GUIDEWIRE. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED THE CAT7 TO THE TARGET VESSEL USING A GUIDEWIRE AND COMPLETED ONE PASS. WHILE ADVANCING AND TORQUING THE CAT7 IN THE DISTAL SFA DURING THE SECOND PASS, THE CAT7 BROKE OFF NEAR THE DISTAL ONE THIRD; THEREFORE, THE CAT7 WAS REMOVED. THE PHYSICIAN THEN PERFORMED AN OPEN SURGERY VIA CUTDOWN TECHNIQUE TO REMOVE THE BROKEN DISTAL THIRD OF THE CAT7. SUBSEQUENTLY, THE PHYSICIAN PERFORMED A FASCIOTOMY BEFORE ENDING THE PROCEDURE. IT WAS REPORTED BY THE PHYSICIAN THAT THE OPEN SURGERY VIA CUTDOWN TECHNIQUE AND THE FASCIOTOMY WERE NEEDED FOR THE PATIENT EVEN IF THE CAT7 DIDN¿T BREAK IN THE PATIENT. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    867141 INDIGO SYSTEM LIGHTNING 7 QEW QEW PENUMBRA, INC. LITNG7XTORQ130-A F103322 00815948022584

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Required Intervention