BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENUMBRA SYSTEM ACE 68 HI-FLOW KIT

    MDR report key: 6366850 · Received February 28, 2017

    Report

    Report Number
    3005168196-2017-00268
    Event Type
    Malfunction
    Date Received
    February 28, 2017
    Date of Event
    January 29, 2017
    Report Date
    January 31, 2017
    Manufacturer
    PENUMBRA, INC.
    Product Code
    NRY
    UDI-DI
    00814548016603
    PMA / PMN Number
    K161640
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). RESULTS: THE PENUMBRA SYSTEM ACE 68 REPERFUSION CATHETER (ACE 68) WAS FRACTURED APPROXIMATELY 112.0 CM FROM THE HUB. CONCLUSIONS: EVALUATION OF THE RETURNED DEVICE CONFIRMED THAT THE ACE 68 WAS FRACTURED. THIS TYPE OF DAMAGE TYPICALLY OCCURS DUE TO IMPROPER HANDLING DURING REMOVAL FROM THE PACKAGING. IF THE ACE 68 IS WITHDRAWN FROM ITS PACKAGING SHELL AT EXTREME ANGLES BEFORE REMOVING THE TUBING TRAY, DAMAGE SUCH AS THIS MAY OCCUR. PENUMBRA CATHETERS ARE VISUALLY 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

    DURING PREPARATION FOR A THROMBECTOMY PROCEDURE, THE PENUMBRA SYSTEM ACE 68 REPERFUSION CATHETER (ACE 68) SNAPPED AND BROKE AROUND THE DISTAL END WHILE THE RADIOLOGIC TECHNOLOGIST WAS REMOVING THE ACE 68 FROM ITS PACKAGING SHELL. THE ACE 68 BROKE PRIOR TO USE AND THEREFORE, WAS NOT USED IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING A NEW PENUMBRA SYSTEM ACE 68 HI-FLOW KIT (KIT).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    149310 PENUMBRA SYSTEM ACE 68 HI-FLOW KIT NRY NRY PENUMBRA, INC. F72687 00814548016603

    Patients

    Seq Age Sex Outcome Treatment
    1