BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEURON DELIVERY CATHETER

    MDR report key: 2625505 · Received September 23, 2009

    Report

    Report Number
    3005168196-2009-00051
    Event Type
    Malfunction
    Date Received
    September 23, 2009
    Date of Event
    September 1, 2009
    Report Date
    September 22, 2009
    Manufacturer
    PENUMBRA, INC.
    Product Code
    DQY
    PMA / PMN Number
    K082290
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE UNIT WAS RETURNED INSIDE A ZIPLOCK BIOHAZARD LABELED SPECIMEN BAG. THE UNIT WAS DECONTAMINATED WITH A 1:10 DILUTION OF HOUSEHOLD BLEACH. THERE IS OVALIZATION BETWEEN 0.0 CM AND 0.8 CM FROM THE DISTAL TIP. THERE IS A FLAT SPOT BETWEEN 9.5 AND 10.2 CM AND A FLAT SPOT WITH A 1/2 TWIST BETWEEN 14.5 AND 15.8 CM FROM THE DISTAL TIP. THERE IS A MINOR SINGLE AXIS BEND AT 20.0 CM AND A MAJOR SINGLE AXIS BEND AT 20.8 CM. MEASURING FROM THE HUB JOINT THERE ARE MINOR FLAT SPOTS AT 19.5 - 20.0 CM, 42.3 - 45.0 CM AND 45.2 - 46.0 CM. THE INCIDENT IS CONFIRMED AS REPORTED. THE FLAT SPOTS OBSERVED ON THE PROXIMAL PORTION OF THE CATHETER ARE CONSISTENT WITH DAMAGE DURING SHIPPING AND MOST LIKELY HAPPENED POST USE. THE DHR OF THIS MANUFACTURING LOT HAS BEEN REVIEWED. (B)(4), THIS DEFECT, IF NOT DISCOVERED, COULD CONTRIBUTE TO INJURY OR DEATH. INCIDENT # (B)(4). PART # 2314-04.A. NEURON DC 070 95CMX6CM, SHAPED TIP. LOT # F15555 (SAME AS L15555). QTY: 1. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS COMPLETED ON PART # 2314-04 (LOT # L15555). ALL APPROPRIATE INSPECTIONS WERE COMPLETED PER PROCESS MONITORING REQUIREMENTS OR 100% INSPECTIONS WHERE REQUIRED. IN ADDITION, ALL DESTRUCTIVE TESTING WAS COMPLETED PER REQUIRED PROCESS MONITORING REQUIREMENTS AND RESULTS MEET SPECIFICATION FOR THE TENSILE STRENGTH. ALL PARTS THAT FAILED VISUAL INSPECTION HAVE BEEN REJECTED AND ALL PARTS RELEASED MET SPECIFICATIONS. THE PARTS RELEASED IN THIS LOT MET PROCESS REQUIREMENTS. THIS LOT WAS ASSOCIATED WITH (B)(4). THE LOT WAS 100% SORTED AND (B)(4) UNITS WERE REJECTED.

    Description of Event or Problem · 1

    THE PT HAD A VERY TORTUOUS ANATOMY WITH CALCIFIED ARTERIES. THE PHYSICIAN HAD TO ACCESS HER CAROTID ARTERY THROUGH THE BRACHIAL ARTERY (INSTEAD OF FEMORAL). THEY USE A COOK SLIPCATH INSIDE OF THE NEURON FOR ACCESS, AS THEY USUALLY DO. WHEN THEY REMOVED THE INNER CATHETER AFTER THEY HAD ACCESS, THE NEURON KINKED. THE PT IS DOING FINE AND THE PROCEDURE WENT WELL WITH ANOTHER CATHETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEURON DELIVERY CATHETER PERCUTANEOUS CATHETER DQY PENUMBRA, INC. F15555

    Patients

    Seq Age Sex Outcome Treatment
    1