BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENUMBRA COIL 400

    MDR report key: 2043060 · Received February 24, 2011

    Report

    Report Number
    3005168196-2011-00065
    Event Type
    Malfunction
    Date Received
    February 24, 2011
    Date of Event
    January 26, 2011
    Report Date
    January 26, 2011
    Manufacturer
    PENUMBRA, INC.
    Product Code
    KRD
    PMA / PMN Number
    K103305
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS NOT RETURNED FOR EVALUATION. WITHOUT THE RETURN OF THE DEVICE, THE ROOT CAUSE OF THE PROBLEM CANNOT BE DETERMINED. THE MANUFACTURING RECORDS FOR THIS LOT WAS REVIEWED AND DID NOT REVEAL ANY OUTSTANDING DISCREPANCIES, QUALITY, OR DESIGN CONCERNS.

    Description of Event or Problem · 1

    THE PHYSICIAN USED THE PENUMBRA COIL 400 ON A PATIENT PRESENTING AN ICA GIANT ANEURYSM. THE PHYSICIAN DECIDED UPON DEPLOYING THE 3RD COIL OF THE CASE THAT HE HAD SELECTED TOO LARGE OF A COIL. HE ATTEMPTED TO DEPLOY THE COIL BUT WAS FEELING SOME RESISTANCE. HE ATTEMPTED TO REMOVE THE COIL BUT IT WAS NOT LONGER ATTACHED TO THE PUSHER. HE WAS ABLE TO PUSH THE COIL INTO THE ANEURYSM AFTER REPOSITIONING HIS CATHETER WITHOUT ANY PROBLEMS. UPON DEPLOYING THE 5TH COIL OF THE CASE, THE MICROCATHETER WAS KICKED OUT OF THE ANEURYSM. THE PHYSICIAN ATTEMPTED SEVERAL TIMES TO ADVANCE THE CATHETER OVER THE COIL AND BACK INTO THE ANEURYSM. HE WAS UNABLE TO REACCESS THE ANEURYSM IN THIS WAY. AFTER MULTIPLE ATTEMPTS IT APPEARED THAT THE COIL BECAME TANGLED WITH THE STENT THAT WAS ACROSS THE NECK OF THE ANEURYSM. WHEN THE PHYSICIAN ATTEMPTED TO REMOVE THE COIL, HE FELT SIGNIFICANT RESISTANCE AND THE COIL COULD NOT BE REMOVED, BUT IT DETACHED FROM THE PUSHER AND THE PUSHER WAS REMOVED. PART OF THE COIL WAS THEN REMOVED WITH TWO DIFFERENT RETRIEVAL DEVICES. THIS MDR IS ASSOCIATED WITH MDR 3005168196-2011-00064.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PENUMBRA COIL 400 KRD PENUMBRA, INC. F17212

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR