BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INDIGO SYSTEM CATD ASPIRATION CATHETER

    MDR report key: 8527230 · Received April 18, 2019

    Report

    Report Number
    3005168196-2019-00751
    Event Type
    Malfunction
    Date Received
    April 18, 2019
    Date of Event
    March 21, 2019
    Report Date
    March 21, 2019
    Manufacturer
    PENUMBRA, INC.
    Product Code
    DXE
    PMA / PMN Number
    K142870
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS NOT RETURNED FOR EVALUATION. WITHOUT THE RETURN OF THE DEVICE, THE ROOT CAUSE OF THE PROBLEM CANNOT BE DETERMINED. THE MANUFACTURING RECORDS FOR THIS LOT WERE REVIEWED AND DID NOT REVEAL ANY OUTSTANDING DISCREPANCIES, DESIGN, OR QUALITY CONCERNS. ADDITIONAL 510(K)#S THAT ALSO APPLY TO THIS COMPLAINT: K160533, K161523.

    Description of Event or Problem · 1

    THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE BRACHIAL ARTERY USING AN INDIGO SYSTEM CATD ASPIRATION CATHETER (CATD). DURING THE PROCEDURE, THE PHYSICIAN ADVANCED THE CATD INTO A NON-PENUMBRA SHEATH USING THE PEEL AWAY SHEATH. WHILE PULLING BACK THE PEEL AWAY SHEATH TOWARDS THE DISTAL PART OF THE CATD, THE PHYSICIAN EXPERIENCED RESISTANCE; THEREFORE, THE PHYSICIAN DECIDED TO PEEL OFF THE PEEL AWAY SHEATH AND NOTICED THE DISTAL PART OF THE CATD HAD BECOME KINKED. IT WAS REPORTED THAT THE PHYSICIAN CONTINUED WITH THE PROCEDURE WITH THE SAME CATD; HOWEVER, HE WAS NOT SATISFIED WITH THE RESULT. THEREFORE, THE CATD WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW CATD WITH THE SAME ACCESS SHEATH. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    320995 INDIGO SYSTEM CATD ASPIRATION CATHETER DXE DXE PENUMBRA, INC. F87218

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR