BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENUMBRA SYSTEM SEPARATOR 032

    MDR report key: 2013689 · Received February 4, 2011

    Report

    Report Number
    3005168196-2011-00048
    Event Type
    Malfunction
    Date Received
    February 4, 2011
    Date of Event
    October 30, 2009
    Report Date
    October 30, 2009
    Manufacturer
    PENUMBRA, INC.
    Product Code
    NRY
    PMA / PMN Number
    K072718
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    TECHNICAL EVAL: THE FIRST SEPARATOR WIRE IS KNOTTED AT THE PROXIMAL HANDLE TRANSITION. THE SECOND SEPARATOR WIRE BROKE AT THE SAME LOCATION. CONCLUSION: THE INCIDENT WAS CONFIRMED AS REPORTED. 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

    TWO 032 SEPARATORS KINKED DURING USE IN A PROCEDURE, ONE OF THE TWO ALSO FRACTURED. BOTH THE KINKS AND THE ONE FRACTURE WERE PROXIMAL. ONE OF THE (B)(4) PROXIMAL KINKS WAS AT A DIAMETER CHANGE JUNCTION. IT WAS NOTED THAT THE PHYSICIAN PULLED THE (B)(4) BACK TOO FAR OUT OF THE CATHETER (OUT OF THE RHV) THEN ADVANCED, CAUSING THE KINKING AND EVENTUALLY THE FRACTURE. THIS MDR IS ASSOCIATED WITH MDR 3005168196-2010-00402.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PENUMBRA SYSTEM SEPARATOR 032 PERCUTANEOUS CATHETER NRY PENUMBRA, INC. F15105

    Patients

    Seq Age Sex Outcome Treatment
    1