BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INDIGO SYSTEM CAT RX ASPIRATION CATHETER

    MDR report key: 14031820 · Received April 6, 2022

    Report

    Report Number
    3005168196-2022-00160
    Event Type
    Injury
    Date Received
    April 6, 2022
    Date of Event
    March 17, 2022
    Report Date
    July 20, 2022
    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
    FL, US
    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

    PLEASE NOTE THAT THIS COMPLAINT WAS SUBMITTED TO THE FDA BY THE USER FACILITY WITH THE FOLLOWING REFERENCE NUMBER: MW5108491. THE FOLLOWING SECTIONS ARE BEING UPDATED BASED ON ADDITIONAL INFORMATION INCLUDED IN THE USER FACILITY REPORT SUBMITTED TO THE FDA: 1. SECTION E. BOX 4. INITIAL REPORTER ALSO SENT REPORT TO FDA 2. SECTION G. BOX 3. REPORT SOURCE 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 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.

    Description of Event or Problem · 0

    THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE ANTERIOR TIBIAL ARTERY USING AN INDIGO SYSTEM CATRX ASPIRATION CATHETER (CATRX) AND A NON-PENUMBRA SHEATH. DURING THE PROCEDURE, WHILE ADVANCING THE CATRX THROUGH THE SHEATH THE PHYSICIAN KINKED THE CATRX; THEN EXPERIENCED RESISTANCE. THE PHYSICIAN THEN CONTINUED ADVANCING THE CATRX THROUGH THE SHEATH AND EXPERIENCED RESISTANCE AGAIN. SUBSEQUENTLY, THE PHYSICIAN DECIDED TO RETRACT AND REMOVE THE CATRX. WHILE RETRACTING THE CATRX, THE PHYSICIAN ALSO EXPERIENCED RESISTANCE AND THEN BROKE THE CATRX IN HALF WITH A PORTION OF THE CATRX REMAINING IN THE TARGET VESSEL. THEREFORE, THE PHYSICIAN REMOVED THE PROXIMAL PIECE OF THE CATRX AND SHEATH. NEXT, THE PHYSICIAN ATTEMPTED TO RETRIEVE THE BROKEN PORTION OF THE CATRX USING A SNARE DEVICE AND A NEW SHEATH; HOWEVER, THE ATTEMPT WAS UNSUCCESSFUL. THEREFORE, AN OPEN SURGERY VIA CUTDOWN TECHNIQUE WAS PERFORMED TO REMOVE THE BROKEN PIECE OF THE CATRX. THE PROCEDURE WAS COMPLETED USING A NEW CATRX AND THE SECOND SHEATH. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2341957 INDIGO SYSTEM CAT RX ASPIRATION CATHETER QEX,QEW QEX PENUMBRA, INC. CATRXKIT C33073 00814548017556

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Male Required Intervention