BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENUMBRA SYSTEM 3MAX REPERFUSION CATHETER

    MDR report key: 3885113 · Received June 19, 2014

    Report

    Report Number
    3005168196-2014-00413
    Event Type
    Malfunction
    Date Received
    June 19, 2014
    Date of Event
    May 10, 2014
    Report Date
    May 23, 2014
    Manufacturer
    PENUMBRA, INC.
    Product Code
    NRY
    PMA / PMN Number
    K113163
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    RESULT: THE 3MAX CATHETER WAS RETURNED INSIDE THE 5MAX CATHETER. CONCLUSION: THE COMPLAINT HAS BEEN EVALUATED. THE COMPLAINT INDICATES THAT THE 5MAX CATHETER AND 3MAX CATHETER WERE USED COAXIALLY TO ADVANCE TO THE FRONT OF THE THROMBUS. ASPIRATION WAS PERFORMED WITH THE 5MAX CATHETER. UPON REINSERTING THE 3MAX CATHETER INSIDE THE 5MAX CATHETER IN ORDER TO REPOSITION THE 5MAX, THE OPERATOR NOTED THAT THE 3MAX CATHETER WOULD NOT ADVANCE THROUGH THE PROXIMAL END OF THE 3MAX CATHETER SHAFT. DURING INVESTIGATION OF THE RETURNED DEVICES, THE 3MAX CATHETER WAS REMOVED FROM THE LUMEN OF THE 5MAX CATHETER AND THE LUMEN OF THE 3MAX CATHETER WAS EVALUATED AND FOUND TO BE WITHIN SPECIFICATION WITHOUT ANY VISIBLE DEFECTS. HOWEVER, EVALUATION OF THE 5MAX CATHETER CONFIRMED A 4.5 CM OVALIZATION IN THE PROXIMAL SHAFT OF THE CATHETER. THIS OVALIZATION PREVENTED THE 3MAX CATHETER FROM ADVANCING THROUGH THE 5MAX CATHETER. THE CAUSE OF THE OVALIZATION IS CONSISTENT WITH OVER TIGHTENING OF THE RHV ON THE CATHETER SHAFT DURING USE AND PULLING THE CATHETER THROUGH WITHOUT LOOSENING THE RHV. THE MANUFACTURING RECORDS FOR THIS LOT WERE REVIEWED AND DID NOT REVEAL ANY OUTSTANDING DISCREPANCIES, DESIGN, OR QUALITY CONCERNS. THIS MDR IS ASSOCIATED WITH MDR 3005168196-2014-00412.

    Description of Event or Problem · 1

    THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE MIDDLE CEREBRAL ARTERY (MCA) USING A PENUMBRA SYSTEM 5MAX REPERFUSION CATHETER AND A 3MAX REPERFUSION CATHETER. DURING THE PROCEDURE, THE 5MAX REPERFUSION CATHETER AND 3MAX REPERFUSION CATHETER WERE USED COAXIALLY TO REACH THE THROMBUS. ASPIRATION WAS ADMINISTERED WITH THE 5MAX REPERFUSION CATHETER AND A PUMP. THE 3MAX REPERFUSION CATHETER WAS INSERTED INTO THE 5MAX REPERFUSION CATHETER AGAIN IN ORDER TO REPOSITION THE DEVICE; HOWEVER, THE PHYSICIAN EXPERIENCED RESISTANCE. BOTH CATHETERS WERE RETRIEVED. THE PHYSICIAN ATTEMPTED TO RE-INSERT THE 3MAX REPERFUSION CATHETER AND THE CATHETER WOULD NOT PASS THROUGH. A MICRO GUIDE WIRE COULD PASS THROUGH THE 5MAX REPERFUSION CATHETER. ASPIRATION WAS COMPLETED WITH A 4MAX REPERFUSION CATHETER, A PX SLIM DELIVERY MICROCATHETER AND A PUMP. THE PATIENT'S CONDITION IS WELL. PHYSICIAN'S COMMENT: OVER TIGHTENED Y CONNECTOR PROBABLY NARROWED THE LUMEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    361279 PENUMBRA SYSTEM 3MAX REPERFUSION CATHETER NRY NRY PENUMBRA, INC. F35824

    Patients

    Seq Age Sex Outcome Treatment
    1