BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEURON DELIVERY CATHETER 070 ADVANCED

    MDR report key: 1547468 · Received November 13, 2009

    Report

    Report Number
    3005168196-2009-00094
    Event Type
    Malfunction
    Date Received
    November 13, 2009
    Date of Event
    October 14, 2009
    Report Date
    October 14, 2009
    Manufacturer
    PENUMBRA, INC.
    Product Code
    DQY
    PMA / PMN Number
    K082290
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    TECHNICAL EVAL: THERE WERE TWO SINGLE AXIS BENDS IN THE CATHETER AT 0.3 AND 9.5CM FROM THE DISTAL TIP. THERE WERE OVALIZATIONS AT 1.0-1.6CM AND 4.0-4.5CM FROM THE DISTAL TIP. THE INCIDENT WAS CONFIRMED AS REPORTED. A DHR OF THIS MFG LOT HAS BEEN REVIEWED. AS PER FDA GUIDANCE ON 08/28/2009, CATHETER KINKS ARE REPORTABLE INCIDENTS (INCLUDING OUT-OF-BOX-FAILURES). A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS COMPLETED ON PART# 2314-01, (LOT # L15475). ALL APPROPRIATE INSPECTIONS WERE COMPLETED FOR PROCESS MONITORING REQUIREMENTS OR 100% INSPECTIONS WHERE REQUIRED. IN ADDITION, ALL DESTRUCTIVE TESTING WAS COMPLETED PER REQUIRED PROCESS MONITORING REQUIREMENTS AND RESULTS MET SPECIFICATION. ALL PARTS THAT FAILED VISUAL INSPECTION HAVE BEEN REJECTED AND ALL PARTS RELEASED MET SPECIFICATIONS. THE PARTS RELEASED IN THIS LOT MET PROCESS REQUIREMENT.

    Description of Event or Problem · 1

    CATHETER OVALIZATION WHEN PUTTING THE CATHETER ON THE GUIDE WIRE. IT WAS UNCLEAR WHETHER THE CATHETER WAS OVALIZED BY THE TECH PUTTING IT ON THE GUIDE WIRE OR IF THE OVALIZATION OCCURRED IN THE PACKAGING. A REPLACEMENT CATHETER WAS AVAILABLE TO FINISH THE CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEURON DELIVERY CATHETER 070 ADVANCED SUBCUTANEOUS CATHETER DQY PENUMBRA, INC. F15475

    Patients

    Seq Age Sex Outcome Treatment
    1