BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INDIGO SYSTEM ASPIRATION CATHETER 7D

    MDR report key: 17936041 · Received October 13, 2023

    Report

    Report Number
    3005168196-2023-00463
    Event Type
    Malfunction
    Date Received
    October 13, 2023
    Date of Event
    September 18, 2023
    Report Date
    October 27, 2023
    Manufacturer
    PENUMBRA, INC.
    Product Code
    QEW
    UDI-DI
    00815948023970
    PMA / PMN Number
    K193595
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL 510(K) NUMBER THAT ALSO APPLIES TO THIS COMPLAINT: K210083. 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 · 0

    EVALUATION OF THE RETURNED CAT7D CONFIRMED A FRACTURE ON THE CATHETER SHAFT. THIS DAMAGE LIKELY OCCURRED DURING MANIPULATION OF THE CATHETER WITH ASPIRATION TO REMOVE CLOT IN THE VESSEL. IF THE DEVICE IS REPEATEDLY MANIPULATED AGAINST TOUGH CLOT DURING USE, THE CATHETER SHAFT MAY FATIGUE AND SUBSEQUENTLY FRACTURE. FURTHER EVALUATION REVEALED AN ADDITIONAL FRACTURE AND KINKS ON THE CAT7D. BASED ON THE REPORTED EVENT, THE ADDITIONAL FRACTURE IS INCIDENTAL TO THE REPORTED COMPLAINT AND WAS MADE IN AN ATTEMPT TO REMOVE THE FRACTURED DISTAL SEGMENT OF THE CATHETER FROM THE SHEATH. THE ROOT CAUSE OF THE KINKS COULD NOT BE DETERMINED. PENUMBRA DEVICES ARE VISUALLY 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. H3 OTHER TEXT : PLACEHOLDER.

    Description of Event or Problem · 0

    THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE CEPHALIC VEIN GRAFT USING AN INDIGO SYSTEM ASPIRATION CATHETER 7D (CAT7D) AND A NON-PENUMBRA SHEATH. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED THE CAT7D THROUGH THE SHEATH AND TO THE FACE OF THE CLOT IN THE ARTERIOVENOUS (AV) GRAFT. WHILE ADVANCING AND RETRACTING THE CAT7D WITH ASPIRATION FOR APPROXIMATELY 90 SECONDS TO REMOVE CLOT IN THE VESSEL, THE PHYSICIAN FRACTURED THE CAT7D AT THE PROXIMAL END THAT WAS OUTSIDE OF THE SHEATH¿S VALVE. IT WAS REPORTED THAT APPROXIMATELY ONE INCH OF THE FRACTURED CAT7D WAS OUTSIDE OF THE SHEATH. THE PHYSICIAN INSERTED A GUIDEWIRE THROUGH THE FRACTURED CAT7D AND THEN INTENTIONALLY CUT THE PROXIMAL END OF THE CAT7D TO ADVANCE THE GUIDEWIRE FURTHER THROUGH THE CAT7D. AFTERWARDS, THE PHYSICIAN WAS ABLE TO PULL AND REMOVE THE FRACTURED CAT7D AND GUIDEWIRE TOGETHER AS A UNIT OUT FROM THE SHEATH. THE PROCEDURE WAS COMPLETED USING AN INDIGO SYSTEM ASPIRATION CATHETER 7 (CAT7), THE SAME SHEATH, AND THE SAME GUIDEWIRE. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1552060 INDIGO SYSTEM ASPIRATION CATHETER 7D QEW QEW PENUMBRA, INC. H00002356 00815948023970

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Male