BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INDIGO SYSTEM CAT RX ASPIRATION CATHETER

    MDR report key: 10814224 · Received November 9, 2020

    Report

    Report Number
    3005168196-2020-01944
    Event Type
    Injury
    Date Received
    November 9, 2020
    Date of Event
    October 11, 2020
    Report Date
    October 13, 2020
    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
    MS, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    PLEASE NOTE THAT THE FOLLOWING SECTION WAS UPDATED: 1. SECTION B. BOX 5. DESCRIBE EVENT OR PROBLEM EVALUATION OF THE RETURNED CATRX CONFIRMED A FRACTURE ON ITS MID-SHAFT. IT WAS REPORTED THE CATRX WAS ADVANCED TO TARGET ANATOMY WITHOUT A GUIDE CATHETER. IF THE CATRX IS ADVANCED SUCH THAT THE PROXIMAL END OF THE GUIDEWIRE LUMEN IS EXPOSED WITHIN PATIENT ANATOMY, RESISTANCE AND CATHETER DAMAGE WILL LIKELY RESULT. ADDITIONALLY, STENOSIS WAS REPORTED WITHIN THE PATIENT ANATOMY. THE LACK OF GUIDE CATHETER AND STENOSIS LIKELY CONTRIBUTED TO THE RESISTANCE EXPERIENCED DURING THE PROCEDURE. FORCEFUL MANIPULATION AGAINST THE EXPERIENCED RESISTANCE LIKELY CONTRIBUTED TO THE DISTAL CATRX FRACTURE, STRETCHING, AND GUIDEWIRE LUMEN DAMAGE FOUND ON THE RETURNED DEVICE. THE SNARE LIKELY CONTRIBUTED TO ADDITIONAL DAMAGE ON THE DISTAL FRACTURED SEGMENT. THE PROXIMAL FRACTURES WERE INCIDENTAL TO THE COMPLAINT AND MAY HAVE OCCURRED DURING PACKAGING FOR THE DEVICE RETURN. 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.

    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), A SHORT NON-PENUMBRA SHEATH (TERUMO) AND A GUIDEWIRE (.014). IT WAS NOTED THAT THERE WAS STENOSIS IN THE TARGET VESSEL. DURING THE PROCEDURE, THE PHYSICIAN INSERTED THE 11CM SHORT SHEATH INTO THE PATIENT¿S BODY, THEN ADVANCED THE CATRX WITH A GUIDEWIRE OVER THE AORTIC BIFURCATION AND DOWN TO THE TARGET ANATOMY. THE PHYSICIAN THEN COMPLETED SEVERAL PASSES USING THE CATRX. IT WAS REPORTED THAT SOME RESISTANCE WAS ENCOUNTERED WHILE ADVANCING AND RETRACTING THE CATRX. WHILE RETRACTING THE CATRX DURING ANOTHER PASS, THE PHYSICIAN BROKE THE CATRX. THEREFORE, THE CATRX WAS PULLED OUT AND THE DISTAL END WAS SNARED. THE PROCEDURE ENDED AT THIS POINT. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RETURNED AND THE INVESTIGATION RESULTS ARE PENDING. 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 IN THE ANTERIOR TIBIAL ARTERY USING AN INDIGO SYSTEM CATRX ASPIRATION CATHETER (CATRX), A SHORT NON-PENUMBRA SHEATH AND A GUIDEWIRE (.014). IT WAS NOTED THAT THERE WAS STENOSIS IN THE TARGET VESSEL. DURING THE PROCEDURE, THE PHYSICIAN INSERTED THE SHORT SHEATH INTO THE PATIENT¿S BODY, THEN ADVANCED THE CATRX WITH A GUIDEWIRE OVER THE AORTIC BIFURCATION AND DOWN TO THE CLOT TO PERFORM ASPIRATION. THE PHYSICIAN THEN COMPLETED SEVERAL PASSES USING THE CATRX. IT WAS REPORTED THAT SOME RESISTANCE WAS ENCOUNTERED WHILE ADVANCING AND RETRACTING THE CATRX. WHILE RETRACTING THE CATRX DURING ANOTHER PASS, THE PHYSICIAN FELT THE CATRX ¿GIVE¿. SUBSEQUENTLY, THE PHYSICIAN NOTICED THAT THE DISTAL END OF THE CATRX HAD BROKEN OFF. THEREFORE, THE CATRX WAS PULLED OUT AND THE DISTAL END WAS SNARED. THE PROCEDURE ENDED AT THIS POINT. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1278350 INDIGO SYSTEM CAT RX ASPIRATION CATHETER QEX, QEW QEX PENUMBRA, INC. CATRXKIT F98206 00814548017556

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention