BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENUMBRA MICROCATHETER 025 SLIM

    MDR report key: 2883935 · Received December 21, 2012

    Report

    Report Number
    3005168196-2012-00445
    Event Type
    Malfunction
    Date Received
    December 21, 2012
    Date of Event
    December 20, 2012
    Report Date
    December 26, 2012
    Manufacturer
    PENUMBRA, INC.
    Product Code
    DQY
    PMA / PMN Number
    K100826
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE 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 WERE REVIEWED AND DID NOT REVEAL ANY OUTSTANDING DISCREPANCIES, QUALITY, OR DESIGN CONCERNS.

    Description of Event or Problem · 1

    THE PATIENT UNDERWENT COIL EMBOLIZATION FOR ANEURYSM IN MCA BIFURCATION. DUE TO OCCLUDED LOWER EXTREMITIES, A DECISION WAS MADE TO ACCESS THE ANEURYSM THROUGH THE RIGHT BRACHIAL ARTERY. ADVANCEMENT OF THE PENUMBRA MICROCATHETER AND SYNCHRO 2 SOFT MICROWIRE WERE UNSUCCESSFUL. THE SYNCHRO WAS EXCHANGED FOR AN EXPEDION 10 BUT THEN THE PENUMBRA MICROCATHETER KINKED. A 45 DEGREE PENUMBRA MICROCATHETER WAS EXCHANGED BUT WAS ALSO KINKED. THIS WAS REMOVED AND A NEW 45 DEGREE PENUMBRA MICROCATHETER WAS INSERTED TO ACCESS R MCA WITH NO COMPLICATIONS. THE TWO KINKED CATHETERS WERE NOT ASSOCIATED WITH ANY ADVERSE EVENTS. FOLLOWING THIS CASE THE COIL EMBOLIZATION CONTINUED. THE FIRST THREE COIL INSERTIONS RESULTED IN PARTIAL OCCLUSION OF THE M2 AND WERE REMOVED. THE PHYSICIAN THEN CHOSE TO UNDERSIZE THE FOLLOWING COILS IN ORDER TO AVOID DISLODGMENT AND SEVEN COILS WERE DEPLOYED INTO THE ANEURYSM. RAYMOND I OCCLUSION WAS ACHIEVED IN ONE HALF AND III IN ANOTHER. PATIENT AWOKE IN PREANGIOGRAPHIC NEUROLOGIC CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PENUMBRA MICROCATHETER 025 SLIM DQY DQY PENUMBRA, INC. F28433

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR