BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENUMBRA SYSTEM SEPARATOR 026

    MDR report key: 2053434 · Received March 1, 2011

    Report

    Report Number
    3005168196-2011-00062
    Event Type
    Malfunction
    Date Received
    March 1, 2011
    Date of Event
    January 26, 2011
    Report Date
    January 31, 2011
    Manufacturer
    PENUMBRA, INC.
    Product Code
    NRY
    PMA / PMN Number
    K072718
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE INVESTIGATION: THE DISTAL END OF THE SEPARATOR WAS RETURNED, MEASURING 153 CM IN LENGTH. THE BROKEN END IS KNOTTED AND KINKED. THE PROXIMAL SECTION OF THE DEVICE WAS NOT RETURNED. THE BREAK IS IN THE REGION OF THE PROXIMAL TAPER GRIND. THIS DAMAGE HAS BEEN SEEN WHEN THE SEPARATOR TAPER GRIND REGION IS MANIPULATED OUTSIDE OF THE RHV DURING USE. THE MFG RECORDS FOR THIS DEVICE WERE REVIEWED AND DID NOT REVEAL ANY OUTSTANDING DISCREPANCIES, DESIGN OR QUALITY CONCERNS.

    Description of Event or Problem · 1

    DURING AN ACUTE STROKE CASE, THE PHYSICIAN ADVANCED A PENUMBRA SYS REPERFUSION CATHETER 026 INTO A DISTAL A2 SEGMENT OVER A GUIDEWIRE. THE PHYSICIAN THEN REMOVED THE GUIDEWIRE AND INTRODUCED THE 026 SEPARATOR WITH NO SIGNIFICANT RESISTANCE ENCOUNTERED. WHILE WORKING AT THE CLOT FOR APPROX 5 - 7 MINUTES WITH THE SEPARATOR, ON THE BACKWARD SEPARATOR MOTION, THE ENTIRE PUSH ROD SUPPORT SECTION FOR THE SEPARATOR BROKE AT THE STEP DOWN JUNCTION 45 CM FROM THE RHV AND WAS WITHDRAWN FROM THE REPERFUSION CATHETER LEAVING THE REMAINING PORTION OF THE SEPARATOR STILL INSIDE THE REPERFUSION CATHETER. THE PHYSICIAN WAS ABLE TO VISUALLY OBSERVE THE BROKEN SEPARATOR INSIDE THE CATHETER AND PROCEEDED TO REMOVE THE BROKEN PORTION WITH THE AID OF A SURGICAL MOSQUITO CLAMP DEVICE. THE PHYSICIAN WAS SUCCESSFUL AT RETRIEVING THE ENTIRE FRACTURED COMPONENT. THE PHYSICIAN THEN REMOVED A NEW SEPARATOR FROM THE INVENTORY AND SUCCESSFULLY COMPLETED THE CASE WITHOUT ANY ADD'L DEVICE ISSUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PENUMBRA SYSTEM SEPARATOR 026 NRY PENUMBRA, INC. F12488

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR