BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INDIGO SYSTEM CATRX ASPIRATION CATHETER

    MDR report key: 10653929 · Received October 8, 2020

    Report

    Report Number
    3005168196-2020-01673
    Event Type
    Injury
    Date Received
    October 8, 2020
    Date of Event
    September 14, 2020
    Report Date
    September 14, 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
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    RESULTS: THE CATRX WAS KINKED APPROXIMATELY 47.0 CM, 49.0 CM AND 72.0 CM FROM THE HUB. THE DEVICE WAS FRACTURED AT APPROXIMATELY 75.0 CM FROM THE HUB. THE DISTAL FRACTURED SEGMENT WAS NOT RETURNED FOR EVALUATION. CONCLUSIONS: EVALUATION OF THE RETURNED CATRX CONFIRMED A MID-SHAFT FRACTURE. BASED ON THE DAMAGE AT THE FRACTURE SITE, IT IS LIKELY AT A KINK OCCURRED PRIOR TO FRACTURE. IF THE DEVICE IS FORCEFULLY ADVANCED AGAINST RESISTANCE OR MANIPULATED AT AN EXTREME ANGLE, DAMAGE SUCH AS A KINK AND SUBSEQUENTLY FRACTURE MAY OCCUR. THE DISTAL FRACTURED SEGMENT WAS NOT RETURNED FOR EVALUATION. FURTHER EVALUATION OF THE DEVICE REVEALED KINKS. 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.

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS AVAILABLE FOR RETURN. 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 SUPERFICIAL FEMORAL ARTERY (SFA), POPLITEAL ARTERY, AND TIBIALS USING AN INDIGO SYSTEM CATRX ASPIRATION CATHETER (CATRX) AND A NON-PENUMBRA SHEATH. DURING THE PROCEDURE, WHILE MAKING THE SECOND PASS AND ADVANCING THE CATRX ACROSS THE POPLITEAL BELOW THE KNEE, THE PHYSICIAN ENCOUNTERED RESISTANCE. SUBSEQUENTLY, THE DISTAL TIP OF THE CATRX BROKE OFF. THE PHYSICIAN ATTEMPTED TO SNARE THE TIP BUT WAS UNSUCCESSFUL. THEREFORE, THE PATIENT WAS TAKEN TO SURGERY AND THE CATRX TIP WAS SUCCESSFULLY REMOVED. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT AND THE PATIENT'S CURRENT MEDICAL STATUS IS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1117972 INDIGO SYSTEM CATRX ASPIRATION CATHETER QEX, QEW QEX PENUMBRA, INC. CATRXKIT F97743 00814548017556

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention