BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INDIGO SYSTEM ASPIRATION CATHETER 7

    MDR report key: 12021167 · Received June 17, 2021

    Report

    Report Number
    3005168196-2021-01362
    Event Type
    Malfunction
    Date Received
    June 17, 2021
    Date of Event
    May 21, 2021
    Report Date
    July 29, 2021
    Manufacturer
    PENUMBRA, INC.
    Product Code
    QEW
    UDI-DI
    00815948023970
    PMA / PMN Number
    K193595
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    EVALUATION OF THE RETURNED CAT7 CONFIRMED THAT THE DISTAL TIP WAS OVALIZED AND REVEALED ADDITIONAL OVALIZATIONS ALONG THE CATHETER. IF THE DEVICE IS MISHANDLED DURING USE, DAMAGE SUCH AS THIS MAY OCCUR. FURTHER EVALUATION OF THE DEVICE REVEALED THAT THE DISTAL TIP LUMEN WAS FOLDED. THIS DAMAGE WAS LIKELY A RESULT OF FORCEFUL MANIPULATION OF THE DISTAL TIP AGAINST RESISTANCE DURING THE PROCEDURE. THE ROOT CAUSE OF THE RESISTANCE COULD NOT BE DETERMINED. DURING FUNCTIONAL TESTING, THE CAT7 WAS TESTED WITH A DEMONSTRATION PUMP AND CANISTER AND THE CAT7 FUNCTIONING AS INTENDED. 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

    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 TO TREAT ARTERIOVENOUS FISTULA (AVF) USING AN INDIGO SYSTEM ASPIRATION CATHETER 7 (CAT7) A NON-PENUMBRA SHEATH. DURING THE PROCEDURE, THE PHYSICIAN COMPLETED APPROXIMATELY 3 PASSES USING THE CAT7. AFTERWARDS, IT WAS NOTICED THAT THE DISTAL TIP OF THE CAT7 WAS OVALIZED. THE TECHNICIAN TRIED TO FIX THE OVALIZED DISTAL TIP AND SUBSEQUENTLY MADE IT WORSE. THEREFORE, THE CAT7 WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW CAT7 AND THE SAME NON-PENUMBRA SHEATH. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    913164 INDIGO SYSTEM ASPIRATION CATHETER 7 QEW QEW PENUMBRA, INC. CAT7DKIT-A C25050 00815948023970

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR