BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENUMBRA SYSTEM SEPARATOR 032

    MDR report key: 2013694 · Received February 4, 2011

    Report

    Report Number
    3005168196-2011-00045
    Event Type
    Malfunction
    Date Received
    February 4, 2011
    Date of Event
    July 22, 2009
    Report Date
    July 26, 2009
    Manufacturer
    PENUMBRA, INC.
    Product Code
    NRY
    PMA / PMN Number
    K072718
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE INVESTIGATION: THE SEPARATOR WAS RETURNED LODGED INSIDE THE CATHETER WITH PT BLOOD VISIBLE IN THE HUB. THE BULB OF THE SEPARATOR WAS JUST DISTAL TO THE MARKETER BAND OF THE CATHETER. THE SEPARATOR IS BROKEN AT THE PROXIMAL TAPER FROND. THE PROXIMAL WIRE SHOWS SEVERAL BENDS AND A LOOP AT THE END THAT APPEARS TO HAVE BEEN CONSTRAINED BY THE RHV. THE MFG RECORDS FOR THIS LOT WERE REVIEWED AND DID NOT REVEAL ANY OUTSTANDING DISCREPANCIES, DESIGN OR QUALITY CONCERNS.

    Description of Event or Problem · 1

    ONE OF THE CATHETERS STRETCHED ACCORDING TO THE PHYSICIAN. THE (B)(4) SEPARATOR FRACTURED INSIDE THE SECOND CATHETER. THIS MDR IS ASSOCIATED WITH MDR 3005168196-2010-00067 WHICH PERTAINS TO THE PSC032 THAT "STRETCHED".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PENUMBRA SYSTEM SEPARATOR 032 PERCUTANEOUS CATHETER NRY PENUMBRA, INC. F14927

    Patients

    Seq Age Sex Outcome Treatment
    1