BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INDIGO SYSTEM CATRX ASPIRATION CATHETER

    MDR report key: 18871717 · Received March 8, 2024

    Report

    Report Number
    3005168196-2024-00070
    Event Type
    Injury
    Date Received
    March 8, 2024
    Date of Event
    February 16, 2024
    Report Date
    March 27, 2024
    Manufacturer
    PENUMBRA, INC.
    Product Code
    QEX
    UDI-DI
    00814548017556
    PMA / PMN Number
    K220683
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    EVALUATION OF THE RETURNED CATRX CONFIRMED THAT THE CATHETER WAS FRACTURED, AND THE GUIDEWIRE LUMEN WAS DAMAGED. IF THE CATRX IS RETRACTED AGAINST RESISTANCE, DAMAGE SUCH AS A FRACTURE MAY OCCUR. THE REPORTED CATRX WRAPPING AROUND THE GUIDEWIRE LIKELY CONTRIBUTED TO RESISTANCE DURING THE PROCEDURE. IF THE GUIDEWIRE LUMEN IS ADVANCED PAST THE DISTAL TIP OF THE GUIDE SHEATH, DAMAGE SUCH AS THIS MAY OCCUR. FURTHER EVALUATION REVEALED MULTIPLE KINKS AND BENDS ALONG THE CATHETER SHAFT. THIS DAMAGE WAS INCIDENTAL TO THE REPORTED COMPLAINT. MULTIPLE KINKS MAY HAVE OCCURRED DURING THE PROCEDURE. THE BEND ALONG THE CATHETER SHAFT LIKELY OCCURRED DURING PACKAGING OF THE DEVICE FOR RETURN TO PENUMBRA. 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.

    Additional Manufacturer Narrative · 0

    THE DEVICE HAS BEEN RETURNED AND THE INVESTIGATION RESULTS ARE PENDING. A FOLLOW UP MDR WILL BE SUBMITTED UPON COMPLETION OF THE DEVICE INVESTIGATION. H3 OTHER TEXT : PLACEHOLDER.

    Description of Event or Problem · 0

    THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE TIBIOPERONEAL TRUNK (PT TRUNK) IN THE LEFT LEG USING AN INDIGO SYSTEM CATRX ASPIRATION CATHETER (CATRX), A NON-PENUMBRA SHEATH, AND A GUIDE WIRE. DURING THE PROCEDURE, A GUIDE WIRE AND SHEATH WERE ADVANCED TO THE TARGET VESSEL. THE PHYSICIAN THEN ADVANCED A CATRX THROUGH THE SHEATH. WHILE ADVANCING, THE PHYSICIAN WAS UNABLE TO VISUALIZE THE CATRX. NEXT THE ANGIOGRAM REVEALED THAT THE CATRX AND SHEATH WERE IN THE ABDOMINAL AORTA AND IT WAS NOTED THAT THE CATRX WAS WRAPPED AROUND THE GUIDE WIRE. THE PHYSICIAN THEN ATTEMPTED TO RETRACT THE CATRX AND WIRE BACK INTO THE SHEATH; HOWEVER, RESISTANCE WAS MET AND THE CATRX WOULD NOT RETRACT. THE PHYSICIAN THEN ATTEMPTED TO RETRACT THE GUIDE WIRE; HOWEVER, THE SAME ISSUE OCCURRED. IT WAS REPORTED THAT THE WIRE WAS WRAPPED AROUND THE CATRX. SUBSEQUENTLY, THE CATRX FRACTURED AT THE RAPID EXCHANGE LOCATION. THE PROXIMAL END OF THE CATRX WAS REMOVED AND THE DISTAL END OF THE CATRX REMAINED IN THE RIGHT ILIAC ARTERY. A SNARE DEVICE WAS USED TO REMOVE THE FRACTURED PORTION OF THE CATRX FROM THE PATIENT. THE PROCEDURE WAS COMPLETED WITH AN INDIGO SYSTEM ASPIRATION CATHETER 6 (CAT6).

    Description of Event or Problem · 0

    THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE TIBIOPERONEAL TRUNK (PT TRUNK) IN THE LEFT LEG USING AN INDIGO SYSTEM CATRX ASPIRATION CATHETER (CATRX), A NON-PENUMBRA SHEATH, AND A GUIDE WIRE. DURING THE PROCEDURE, A GUIDE WIRE AND SHEATH WERE ADVANCED TO THE TARGET VESSEL. THE PHYSICIAN THEN ADVANCED A CATRX THROUGH THE SHEATH. WHILE ADVANCING, THE PHYSICIAN WAS UNABLE TO VISUALIZE THE CATRX. NEXT THE ANGIOGRAM REVEALED THAT THE CATRX AND SHEATH WERE IN THE ABDOMINAL AORTA, AND IT WAS NOTED THAT THE CATRX WAS WRAPPED AROUND THE GUIDE WIRE. THE PHYSICIAN THEN ATTEMPTED TO RETRACT THE CATRX AND WIRE BACK INTO THE SHEATH; HOWEVER, RESISTANCE WAS MET AND THE CATRX WOULD NOT RETRACT. THE PHYSICIAN THEN ATTEMPTED TO RETRACT THE GUIDE WIRE; HOWEVER, THE SAME ISSUE OCCURRED. IT WAS REPORTED THAT THE WIRE AND CARTX WERE KNOTTED TOGETHER. SUBSEQUENTLY, THE CATRX FRACTURED AT THE RAPID EXCHANGE LOCATION. THE PROXIMAL END OF THE CATRX WAS REMOVED AND THE DISTAL END OF THE CATRX REMAINED IN THE RIGHT ILIAC ARTERY. A SNARE DEVICE WAS USED TO REMOVE THE FRACTURED PORTION OF THE CATRX FROM THE PATIENT. THE PROCEDURE WAS COMPLETED WITH A CAT6.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    156002 INDIGO SYSTEM CATRX ASPIRATION CATHETER QEX, QEW QEX PENUMBRA, INC. F00008149 00814548017556

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Female Required Intervention