BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENUMBRA SYSTEM ASPIRATION PUMP MAX 110

    MDR report key: 8339158 · Received February 14, 2019

    Report

    Report Number
    3005168196-2019-00282
    Event Type
    Malfunction
    Date Received
    February 14, 2019
    Date of Event
    January 11, 2019
    Report Date
    January 16, 2019
    Manufacturer
    PENUMBRA, INC.
    Product Code
    NRY
    UDI-DI
    00814548012773
    PMA / PMN Number
    K160533
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    PLEASE NOTE THAT THE FOLLOWING SECTION WAS INCORRECTLY REPORTED ON THE INITIAL MFR REPORT AND IS BEING CORRECTED ON THIS FOLLOW-UP #01 MFR REPORT: LOT#. RESULTS: THERE WAS NO VISIBLE DAMAGE TO THE PUMP MAX. CONCLUSIONS: EVALUATION OF THE RETURNED DEVICES REVEALED THAT THE CATRX LUMEN WAS BLOCKED WITH COAGULATED BLOOD. IF THE CATRX LUMEN IS NOT CLEARED DURING USE, BLOOD MAY ENTER THE LUMEN AND BEGIN TO COAGULATE. IF THE LUMEN OF THE CATRX IS OCCLUDED FROM COAGULATED BLOOD, ASPIRATION MAY BE AFFECTED. DURING FUNCTIONAL TESTING THE COAGULATED BLOOD WAS REMOVED FROM THE CATRX LUMEN. THE CATRX, ASPIRATION TUBING, CANISTER, AND THE PUMP MAX WERE ALL CONNECTED AS AN ASPIRATION SYSTEM. THE PUMP MAX WAS POWERED ON AND THE CATRX WAS ABLE TO ASPIRATE WITHOUT AN ISSUE. PENUMBRA CATHETERS AND ASPIRATION TUBING ARE VISUALLY INSPECTED DURING IN-PROCESS INSPECTION AND DURING QUALITY INSPECTION AFTER MANUFACTURING. PENUMBRA PUMPS AND CANISTERS ARE VISUALLY INSPECTED AND FUNCTIONALLY TESTED DURING INCOMING INSPECTION BY QUALITY. THE MANUFACTURING RECORDS FOR THIS LOT WERE REVIEWED AND DID NOT REVEAL ANY OUTSTANDING DISCREPANCIES, DESIGN, OR QUALITY CONCERNS. THIS REPORT IS ASSOCIATED WITH MFR REPORT NUMBERS: 1. 3005168196-2019-00280. 2. 3005168196-2019-00281. 3. 3005168196-2019-00283.

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS AVAILABLE FOR RETURN. A FOLLOW UP MDR WILL BE SUBMITTED UPON COMPLETION OF THE DEVICE INVESTIGATION. THIS REPORT IS ASSOCIATED WITH MFR REPORT NUMBERS: 3005168196-2019-00280, 3005168196-2019-00281, 3005168196-2019-00283.

    Description of Event or Problem · 1

    THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE LEFT ANTERIOR DESCENDING ARTERY (LAD) USING AN INDIGO SYSTEM CAT RX KIT AND A PENUMBRA SYSTEM ASPIRATION PUMP MAX 110 (PUMP MAX). DURING THE PROCEDURE, THE PHYSICIAN WAS UNABLE TO ASPIRATE THE CLOT USING AN INDIGO SYSTEM CATRX ASPIRATION CATHETER (CATRX) AND WAS UNABLE TO GET SUCTION THROUGH THE CATRX WITH THE PUMP MAX. THEREFORE, BOTH THE CATRX AND PUMP MAX WERE REMOVED. THE PROCEDURE WAS COMPLETED USING BALLOON ANGIOPLASTY. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    134673 PENUMBRA SYSTEM ASPIRATION PUMP MAX 110 NRY NRY PENUMBRA, INC. F40660-20 00814548012773

    Patients

    Seq Age Sex Outcome Treatment
    1