BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INDIGO SYSTEM CAT RX ASPIRATION CATHETER

    MDR report key: 12450710 · Received September 9, 2021

    Report

    Report Number
    3005168196-2021-01998
    Event Type
    Injury
    Date Received
    September 9, 2021
    Date of Event
    August 19, 2021
    Report Date
    October 1, 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
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    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.

    Additional Manufacturer Narrative · 1

    EVALUATION OF THE RETURNED CATRX CONFIRMED A FRACTURE ON ITS DISTAL SHAFT. EVALUATION ALSO REVEALED THAT THE CATHETER WAS STRETCHED AT THE FRACTURE SITE. IF THE DEVICE IS FORCEFULLY RETRACTED AGAINST RESISTANCE, THE CATHETER WILL LIKELY BECOME STRETCHED. IF THE STRETCHED DEVICE CONTINUES TO BE RETRACTED AGAINST RESISTANCE, IT WILL LIKELY BECOME FRACTURED. FURTHER EVALUATION OF THE DEVICE REVEALED THAT THE GUIDEWIRE LUMEN WAS PUNCTURED. IF THE GUIDEWIRE IS ADVANCED THROUGH THE CATRX GUIDEWIRE LUMEN AT AN EXTREME ANGLE, THE GUIDEWIRE MAY PUNCTURE THE LUMEN. IT WAS REPORTED THE CATRX WAS ADVANCED THROUGH A 7F SHEATH. THIS WOULD ALLOW FOR THE GUIDEWIRE TO BE LOOSE WITHIN ITS LUMEN AND POSSIBLY PROLAPSE. THIS MAY HAVE CONTRIBUTED TO THE RESISTANCE EXPERIENCED WHEN RETRACTING THE CATHETER. THIS RESISTANCE LIKELY CONTRIBUTED TO THE CATHETER FRACTURE DURING THE PROCEDURE. FURTHER EVALUATION OF THE DEVICE REVEALED KINKS ALONG THE LENGTH OF THE CATHETER AND ADDITIONAL DAMAGE TO THE GUIDEWIRE LUMEN. THIS DAMAGE WAS LIKELY INCIDENTAL TO THE COMPLAINT. 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 · 1

    THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE POPLITEAL ARTERY USING AN INDIGO SYSTEM CATRX ASPIRATION CATHETER (CATRX) AND A NON-PENUMBRA SHEATH. IT WAS NOTED THAT THE PATIENT¿S ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, THE PHYSICIAN MADE MULTIPLE PASSES USING THE CATRX. WHILE RETRACTING THE CATRX AFTER COMPLETION OF THE LAST PASS, THE PHYSICIAN EXPERIENCED RESISTANCE AND FELT THAT THE CATRX HAD BROKEN. UPON REMOVAL, IT WAS NOTICED THAT THE CATRX BROKE AT THE MID-SHAFT AND AT THE DISTAL END. THE PHYSICIAN THEN USED A SNARE DEVICE TO REMOVE THE BROKEN CATRX. 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
    1346294 INDIGO SYSTEM CAT RX ASPIRATION CATHETER QEX, QEW QEX PENUMBRA, INC. CATRXKIT F102882 00814548017556

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention