BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENUMBRA SYSTEM REPERFUSION CATHETER 032

    MDR report key: 2013690 · Received February 4, 2011

    Report

    Report Number
    3005168196-2011-00047
    Event Type
    Malfunction
    Date Received
    February 4, 2011
    Date of Event
    October 23, 2009
    Report Date
    October 23, 2009
    Manufacturer
    PENUMBRA, INC.
    Product Code
    NRY
    PMA / PMN Number
    K072718
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    TECHNICAL EVAL: THE SEPARATOR WAS RETURNED LODGED IN THE CATHETER, WITH THE BULB AND DISTAL TIP OF THE SEPARATOR PROTRUDING FROM THE DISTAL TIP OF THE CATHETER. THE SEPARATOR WIRE WAS BROKEN JUST INSIDE THE LURE CONE OF THE HUB. NO PROXIMAL PART OF THE SEPARATOR WAS RETURNED. THE CATHETER SHOWED FLAT SPOTS AT 5.0 AND 9.0CM FROM THE DISTAL TIP. THE INCIDENT WAS CONFIRMED AS REPORTED. BASED ON THE POSITION OF THE SEPARATOR IN THE CATHETER AND THE LENGTH OF THE SEPARATOR PROTRUDING FROM THE DISTAL TIP, THE BREAK APPEARS TO HAVE OCCURRED AT OR JUST DISTAL OF THE PROXIMAL TAPER GRIND. 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

    THE PHYSICIAN HAD DIFFICULTY MOVING THE SEPARATOR AND IT SEEMED TO BE STUCK. THE PHYSICIAN THEN OBSERVED A BREAK IN THE SEPARATOR AND THEN REMOVED THE SEPARATOR AND THE CATHETER TOGETHER. THIS MDR IS ASSOCIATED WITH MDR 3005168196-2009-00100 WHICH PERTAINS TO THE (B)(4).

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1