BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENUMBRA SYSTEM SEPARATOR 032

    MDR report key: 2013704 · Received February 4, 2011

    Report

    Report Number
    3005168196-2011-00039
    Event Type
    Malfunction
    Date Received
    February 4, 2011
    Date of Event
    February 23, 2009
    Report Date
    March 2, 2009
    Manufacturer
    PENUMBRA, INC.
    Product Code
    NRY
    PMA / PMN Number
    K072718
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFO THAT WE HAVE WITH REGARD TO THIS INCIDENT WAS SUPPLIED BY OUR DISTRIBUTOR. WE HAVE NOT BEEN ABLE TO CONTACT THE PHYSICIAN OR HOSPITAL DIRECTLY. THE PRODUCTS WERE NOT RETURNED TO US AND WE ARE FILING THE MDR BASED ON THE INFO WE HAVE RECEIVED. LANGUAGE APPEARS TO BE AN ISSUE AND IT IS UNCLEAR TO US WHETHER "BROKEN" MEANS "DAMAGED" OR "DIDN'T WORK AS EXPECTED".

    Description of Event or Problem · 1

    THE PHYSICIAN USED TWO CATHETERS AND COULD NOT ACHIEVE RE-VASCULARIZATION BECAUSE BOTH THE 041 AND 032 SEPARATORS WERE BROKEN. THIS MDR IS ASSOCIATED WITH MDR 3005168196-2010-00085.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1