BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INDIGO SYSTEM SEPARATOR 6

    MDR report key: 20163108 · Received September 6, 2024

    Report

    Report Number
    3005168196-2024-00308
    Event Type
    Injury
    Date Received
    September 6, 2024
    Date of Event
    July 19, 2024
    Report Date
    October 2, 2024
    Manufacturer
    PENUMBRA, INC.
    Product Code
    QEW
    PMA / PMN Number
    K142870
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    EVALUATION OF THE RETURNED SEP6 CONFIRMED THAT THE SEPARATOR CONE WAS DETACHED. THIS DAMAGE TYPICALLY OCCURS IF THE DISTAL TIP OF THE SEP6 IS REPEATEDLY MANIPULATED THROUGH TOUGH CLOT DURING USE. BASED ON THE REPORTED COMPLAINT, THE ROOT CAUSE OF THIS DAMAGE COULD NOT BE DETERMINED. PENUMBRA DEVICES ARE VISUALLY 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.

    Description of Event or Problem · 0

    THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE LEFT POPLITEAL ARTERY USING AN INDIGO SYSTEM SEPARATOR 6 (SEP6), INDIGO SYSTEM ASPIRATION CATHETER 6 (CAT6), A NON-PENUMBRA CROSSOVER SHEATH, AND A GUIDEWIRE. DURING THE PROCEDURE, THE PHYSICIAN GAINED ACCESS VIA THE RIGHT GROIN USING THE CROSSOVER SHEATH. THE PHYSICIAN THEN ADVANCED THE CAT6 AND SEP6 THROUGH THE SHEATH AND INTO THE TARGET LOCATION. THE CAT6 AND SEP6 WERE USED TO REMOVE SOME OF THE THROMBUS, AND SOME PARTIAL BLOOD FLOW WAS OBSERVED. IT WAS OBSERVED UNDER FLUOROSCOPY THAT THE BULB OF THE SEP6 FRACTURED IN THE POPLITEAL ARTERY. THEREFORE, THE PHYSICIAN DECIDED TO STENT THE BULB OF THE SEP6 IN THE POPLITEAL ARTERY. INITIALLY, IT WAS NOTED THAT IT WAS SUCCESSFUL; HOWEVER, THE BULB OF THE SEP6 MIGRATED TO THE PERONEAL ARTERY. THEREFORE, THE PHYSICIAN MADE MULTIPLE ATTEMPTS WITH A SNARE DEVICE TO SUCCESSFULLY RETRIEVE AND ASPIRATE THE BULB OF THE SEP6 USING THE CAT6. IT WAS REPORTED THAT THE CONTROL IMAGING REVEALED SOME DISTAL SPASM IN THE PERONEAL ARTERY. THE PHYSICIAN THEN ADMINISTERED NITROGLYCERIN TO TREAT THE SPASM. THE FINAL ANGIOGRAM SHOWED A REMAINING SHORT CONTRAST DEFECT IN THE MOST DISTAL PART OF THE PERONEAL ARTERY. THE PROCEDURE ENDED AT THIS POINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1066548 INDIGO SYSTEM SEPARATOR 6 QEW QEW PENUMBRA, INC. H00001595

    Patients

    Seq Age Sex Outcome Treatment
    1 89 YR Female Required Intervention