BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PENUMBRA SYSTEM 3MAX REPERFUSION CATHETER

    MDR report key: 6657182 · Received June 21, 2017

    Report

    Report Number
    3005168196-2017-00948
    Event Type
    Injury
    Date Received
    June 21, 2017
    Date of Event
    May 23, 2017
    Report Date
    May 24, 2017
    Manufacturer
    PENUMBRA, INC.
    Product Code
    NRY
    UDI-DI
    00814548012490
    PMA / PMN Number
    K160449
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PLEASE NOTE THAT THE FOLLOWING DEVICE CODES ALSO APPLY TO THIS COMPLAINT: (B)(4). RESULTS: THE PENUMBRA SYSTEM 3MAX REPERFUSION CATHETER (3MAX) WAS STRETCHED, BEGINNING APPROXIMATELY 117.0 CM FROM THE HUB. THE STRETCHED REGION WAS APPROXIMATELY 40.0 CM LONG, AND THE STRETCHED REGION OF THE 3MAX WAS FRACTURED APPROXIMATELY 140.0 CM FROM THE HUB. THE 3MAX SHAFT WAS KNOTTED APPROXIMATELY 150.0 CM FROM THE HUB. CONCLUSIONS: EVALUATION OF THE RETURNED DEVICE REVEALED THAT THE 3MAX WAS STRETCHED AND FRACTURED. IT IS POSSIBLE FOR THE 3MAX TO BECOME PINNED AGAINST PATIENT ANATOMY, BURDENSOME CLOT, OR OTHER DEVICES USED IN THE PROCEDURE. IF THE 3MAX BECOMES PINNED OR OTHERWISE RESTRAINED AND IS THEN FORCEFULLY RETRACTED, RESISTANCE WILL BE EXPERIENCED, AND DAMAGE SUCH AS THIS MAY OCCUR. FURTHER EVALUATION REVEALED THAT THE 3MAX CATHETER SHAFT WAS KNOTTED. THIS KNOTTING LIKELY OCCURRED DUE TO THE REPORTED PROLAPSE OF THE 3MAX DURING NAVIGATION OF PATIENT ANATOMY AND LIKELY CONTRIBUTED TO THE 3MAX BECOMING PINNED OR RESTRAINED WITHIN THE PATIENT ANATOMY. FURTHER EVALUATION REVEALED THAT THE 3MAX WAS KINKED IN MULTIPLE LOCATIONS. THIS DAMAGE MAY HAVE OCCURRED DUE TO FORCEFUL MANIPULATION OF THE 3MAX WITHIN PATIENT ANATOMY. THE 5MAX ACE MENTIONED IN THE COMPLAINT WAS NOT RETURNED FOR EVALUATION. 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 M1 SEGMENT OF THE RIGHT MIDDLE CEREBRAL ARTERY (MCA) USING A PENUMBRA SYSTEM 3MAX REPERFUSION CATHETER (3MAX). DURING THE PROCEDURE, THE PHYSICIAN ADVANCED THE 3MAX THROUGH A PENUMBRA SYSTEM 5MAX ACE REPERFUSION CATHETER (5MAX ACE) COAXIALLY AND THEN INITIATED ASPIRATION USING THE 3MAX. BECAUSE THE THROMBUS WAS SO HARD, THE 3MAX MADE A LOOP WHEN IT WAS ADVANCED RIGHT AFTER BEING DELIVERED TO THE TARGET M1 SEGMENT. AFTER TWO MINUTES, THE PHYSICIAN REMOVED THE 3MAX FROM THE PATIENT'S BODY AGAINST STRONG RESISTANCE AND NOTICED THAT IT WAS FRACTURED. UNDER FLUOROSCOPY, IT WAS OBSERVED THAT THE DISTAL TIP OF THE 3MAX WAS STILL IN THE PATIENT'S BODY. THEREFORE, THE PHYSICIAN ATTEMPTED TO REMOVE THE FRACTURED TIP USING A SNARE DEVICE AND THEN A BALLOON CATHETER BUT WAS UNSUCCESSFUL. AFTER THREE HOURS, THE FRACTURED TIP WAS REMOVED FROM THE PATIENT USING A STENT RETRIEVER AND THE PROCEDURE THEN ENDED AT THAT POINT. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    437866 PENUMBRA SYSTEM 3MAX REPERFUSION CATHETER NRY NRY PENUMBRA, INC. F72871 00814548012490

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention