BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INDIGO SYSTEM CAT RX ASPIRATION CATHETER

    MDR report key: 11614854 · Received April 5, 2021

    Report

    Report Number
    3005168196-2021-00682
    Event Type
    Injury
    Date Received
    April 5, 2021
    Date of Event
    March 8, 2021
    Report Date
    March 8, 2021
    Manufacturer
    PENUMBRA, INC.
    Product Code
    QEX
    UDI-DI
    00814548017556
    PMA / PMN Number
    K163618
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    PLEASE NOTE THAT THE DEVICE ASSOCIATED WITH THIS COMPLAINT WAS EXPECTED TO BE RETURNED; HOWEVER, ADDITIONAL INFORMATION RECEIVED FROM THE PENUMBRA SALES REPRESENTATIVE INDICATED THAT THE DEVICE WAS DISPOSED OF AND IS NO LONGER AVAILABLE FOR RETURN. THEREFORE, 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. THIS REPORT IS ASSOCIATED WITH MFR REPORT NUMBER: 1.3005168196-2021-00681.

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS AVAILABLE FOR RETURN. A FOLLOW UP MDR WILL BE SUBMITTED UPON COMPLETION OF THE DEVICE INVESTIGATION. THIS REPORT IS ASSOCIATED WITH MFR REPORT NUMBER: 3005168196-2021-00681.

    Description of Event or Problem · 1

    THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE ANTERIOR TIBIAL ARTERY USING AN INDIGO SYSTEM CATRX ASPIRATION CATHETER (CATRX), GUIDE CATHETER (6FR), AND A NON-PENUMBRA SHEATH. IT WAS REPORTED PRIOR TO USING THE CATRX, THE PHYSICIAN PERFORMED A GROIN CUTDOWN TO REMOVE PLAQUE. DURING THE PROCEDURE, WHILE ADVANCING THE CATRX TO MAKE THE FIRST PASS, THE PHYSICIAN EXPERIENCED RESISTANCE AND THE PROXIMAL END OF THE CATRX HAD BENT AND THEN BROKEN INTO TWO PIECES. THEREFORE, IT WAS REMOVED. THE PHYSICIAN THEN ADVANCED A NEW CATRX THROUGH THE SHEATH AND DOWN TO THE DISTAL ANTERIOR TIBIAL ARTERY. SUBSEQUENTLY, THE PHYSICIAN MADE ONE PASS USING THE CATRX; HOWEVER, WHILE RETRACTING THE CATRX, THE PHYSICIAN EXPERIENCED RESISTANCE AND THE DISTAL END OF THE CATRX HAD BROKEN OFF. THEREFORE, THE PHYSICIAN USED A BALLOON CATHETER TO REMOVE THE BROKEN PIECE OF THE CATRX. IT WAS ALSO REPORTED THAT THE PHYSICIAN REMOVED THE SHEATH IN EXCHANGE FOR A NEW SHEATH. AFTERWARDS, THE ARTERIOTOMY WAS CLOSED AND SHUT DOWN THE FEMORAL ARTERY. THE PHYSICIAN PLACED A GRAFT TO RESTORE FLOW AND COMPLETED THE PROCEDURE. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    512437 INDIGO SYSTEM CAT RX ASPIRATION CATHETER QEX, QEW QEX PENUMBRA, INC. CATRXKIT F98465 00814548017556

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention