BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENUMBRA SYSTEM ACE 60 HI-FLOW KIT

    MDR report key: 5929387 · Received September 6, 2016

    Report

    Report Number
    3005168196-2016-01270
    Event Type
    Malfunction
    Date Received
    September 6, 2016
    Date of Event
    August 7, 2016
    Report Date
    August 7, 2016
    Manufacturer
    PENUMBRA, INC.
    Product Code
    NRY
    UDI-DI
    00814548017433
    PMA / PMN Number
    K133317
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS: THE PENUMBRA SYSTEM ACE 60 REPERFUSION CATHETER (ACE 60) WAS STRETCHED FROM APPROXIMATELY 109.0 CM FROM THE HUB. THE STRETCHED SEGMENT WAS APPROXIMATELY 14.0 CM LONG. CONCLUSIONS: EVALUATION OF THE RETURNED ACE 60 REVEALED IT WAS STRETCHED. IT IS POSSIBLE FOR THE DISTAL SEGMENT OF THE ACE 60 TO BECOME RESTRAINED AGAINST PATIENT ANATOMY OR OTHER DEVICES USED IN THE PROCEDURE THAT MAY HAVE PROLAPSED IN THE PATIENT ANATOMY. IF THE DISTAL SEGMENT OF ACE 60 IS PINNED OR OTHERWISE RESTRAINED, AND THEN FORCEFULLY WITHDRAWN AGAINST THE RESISTANCE, THE CATHETER SHAFT MAY BECOME STRETCHED. THE NEURON MAX 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 USING A PENUMBRA SYSTEM ACE 60 REPERFUSION CATHETER (ACE 60) KIT. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED THE ACE 60 THROUGH A NEURON MAX 088(NEURON MAX) AND STARTED ASPIRATION. HOWEVER, WHILE USING THE ACE 60 DURING THE FIRST PASS, THE PHYSICIAN NOTICED THAT FLOW WAS NOT ESTABLISHED AND THEREFORE THE ACE 60 WAS SLOWLY REMOVED. HOWEVER, UPON REMOVING THE ACE 60, THE PHYSICIAN NOTICED IT WAS FLATTENED NEAR THE DISTAL TIP. THE PHYSICIAN THEN ACHIEVED PARTIAL REPERFUSION OF THE TARGET VESSEL USING A NEW ACE 60 WITH THE SAME NEURON MAX AND THE PROCEDURE WAS COMPLETED AT THIS POINT. THERE WAS NO REPORT OF AN ADVERSE EFFECT ON THE PATIENT.

    Description of Event or Problem · 1

    THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE USING A PENUMBRA SYSTEM ACE 60 REPERFUSION CATHETER (ACE 60) KIT. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED THE ACE 60 THROUGH A NEURON MAX 088 (NEURON MAX) AND STARTED ASPIRATION. HOWEVER, WHILE USING THE ACE 60 DURING THE FIRST PASS, THE PHYSICIAN NOTICED THAT FLOW WAS NOT ESTABLISHED AND THEREFORE THE ACE 60 WAS SLOWLY REMOVED. HOWEVER, UPON REMOVING THE ACE 60, THE PHYSICIAN NOTICED IT WAS FLATTENED NEAR THE DISTAL TIP. THE PHYSICIAN THEN ACHIEVED PARTIAL REPERFUSION OF THE TARGET VESSEL USING A NEW ACE 60 WITH THE SAME NEURON MAX AND THE PROCEDURE WAS COMPLETED AT THIS POINT. THERE WAS NO REPORT OF AN ADVERSE EFFECT ON THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    579844 PENUMBRA SYSTEM ACE 60 HI-FLOW KIT NRY NRY PENUMBRA, INC. F67957 00814548017433

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR