BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENUMBRA SYSTEM ACE 64 REPERFUSION CATHETER

    MDR report key: 5746472 · Received June 23, 2016

    Report

    Report Number
    3005168196-2016-00888
    Event Type
    Malfunction
    Date Received
    June 23, 2016
    Date of Event
    May 26, 2016
    Report Date
    May 27, 2016
    Manufacturer
    PENUMBRA, INC.
    Product Code
    NRY
    UDI-DI
    00814548013961
    PMA / PMN Number
    K152541
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    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 NUMBER: 3005168196-2016-00887.

    Additional Manufacturer Narrative · 1

    RESULT: THE PENUMBRA SYSTEM ACE 64 REPERFUSION CATHETER (ACE 64) WAS BENT IN MULTIPLE LOCATIONS ALONG THE DISTAL SHAFT, AND OVALIZED ON THE DISTAL TIP. THE NON-PENUMBRA GUIDEWIRE WAS KINKED IN MULTIPLE LOCATIONS ALONG ITS LENGTH. CONCLUSION: EVALUATION OF THE RETURNED PENUMBRA SYSTEM 3MAX REPERFUSION CATHETER (3MAX) REVEALED IT WAS FRACTURED AND STRETCHED. THIS TYPE OF DAMAGE TYPICALLY OCCURS DUE TO FORCEFUL RETRACTION OF THE 3MAX AGAINST RESISTANCE. IT IS POSSIBLE FOR THE DISTAL SEGMENT OF THE 3MAX 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 IF THE DISTAL SEGMENT OF 3MAX IS PINNED OR OTHERWISE RESTRAINED, AND THEN FORCEFULLY WITHDRAWN AGAINST THE RESISTANCE, THE CATHETER SHAFT MAY BECOME STRETCHED AND FRACTURED. FURTHER EVALUATION REVEALED THE 3MAX WAS KINKED AND OVALIZED ON THE DISTAL TIP. THIS DAMAGE LIKELY OCCURRED DUE TO FORCEFUL MANIPULATION OF THE 3MAX DURING POSITIONING WITHIN ANATOMY. EVALUATION OF THE RETURNED ACE 64 REVEALED IT WAS BENT IN MULTIPLE LOCATIONS ALONG THE DISTAL SHAFT AND OVALIZED ON THE DISTAL TIP. THIS DAMAGE TYPICALLY OCCURS DUE TO FORCEFUL MANIPULATION OF THE ACE 64 DURING USE. THE DAMAGE OBSERVED ON THE ACE 64 MAY HAVE CONTRIBUTED TO THE 3MAX BECOMING STUCK DURING RETRACTION. PENUMBRA CATHETERS ARE 100% VISUALLY INSPECTED DURING IN-PROCESS INSPECTION. 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 PENUMBRA SYSTEM 3MAX REPERFUSION CATHETER (3MAX) AND PENUMBRA SYSTEM ACE 64 REPERFUSION CATHETER (ACE 64). DURING THE PROCEDURE, WHILE BEING USED THROUGH THE ACE 64 TO REMOVE THROMBUS, THE 3MAX WAS PULLED BACK AND IT BECAME STUCK INSIDE THE ACE 64, AND THE 3MAX TIP SEPARATED INSIDE THE ACE 64; THEREFORE, THE PHYSICIAN REMOVED THE ACE 64 WITH THE 3MAX INSIDE AND COMPLETED THE PROCEDURE USING A NEW 3MAX WITH A NEW ACE 64. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    399460 PENUMBRA SYSTEM ACE 64 REPERFUSION CATHETER NRY NRY PENUMBRA, INC. F66625 00814548013961

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR