BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVANCED NEURON DELIVERY CATHETER 070

    MDR report key: 2625556 · Received October 1, 2009

    Report

    Report Number
    3005168196-2009-00067
    Event Type
    Malfunction
    Date Received
    October 1, 2009
    Date of Event
    August 26, 2009
    Report Date
    October 1, 2009
    Manufacturer
    PENUMBRA, INC.
    Product Code
    DQY
    PMA / PMN Number
    K082290
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE UNIT WAS RETURNED IN ITS OPEN STERILE SHEATH WITH ALL PRODUCT LABELING ATTACHED. THE UNIT WAS IDENTIFIED AS REJECTED UPON OPENING AND HAVING NO PT CONTACT. THE UNIT WAS NOT DECONTAMINATED. THERE IS A SINGLE FLAT SPOT EXTENDING FROM 0.5 - 1.8 CM FROM THE DISTAL TIP. A CLOSE EXAMINATION OF THE SHEATH AND THE PROTECTIVE CARRIER TUBE INSIDE IT SHOWED NO DAMAGE OR DEFORMITY. THE INCIDENT IS CONFIRMED BUT NOT AS REPORTED. WHILE ATTEMPTING TO REPLACE THE CATHETER IN ITS PROTECTIVE CARRIER TUBE, IT WAS NOTED THAT THE FLAT SPOT WAS TOO WIDE TO FIT THE TUBE. SINCE THERE IS NO ADDITIONAL CURLING OR DEFORMATION AT THE EDGES OF THE FLAT SPOT, THIS DAMAGE TO THE CATHETER MUST HAVE OCCURRED DURING OR AFTER ITS REMOVAL FROM OUR PACKAGING. THE DHR FOR THIS MFG LOT HAS EEN REVIEWED AND THAT REVIEW IS ATTACHED. CONCLUSION : DEFECT NOTED PRIOR TO USE. AS PER FDA FEEDBACK OF (B)(4) 2009, THIS DEFECT, IF NOT DISCOVERED, COULD CONTRIBUTE TO INJURY OR DEATH. INCIDENT # (B)(4). PART # 2314-02.A. NEURON DC 070 95 CM X 6 CM, STRAIGHT TIP. LOT #F15336 (SAME AS L15336). QTY: 1. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS COMPLETED ON PART #2314-02.A, (LOT # L15336). ALL APPROPRIATE INSPECTIONS WERE COMPLETED PER PROCESS MONITORING REQUIREMENTS OR 100% INSPECTIONS WERE REQUIRED. IN ADDITION, ALL DESTRUCTIVE TESTING WAS COMPLETED PER REQUIRED PROCESS MONITORING REQUIREMENTS AND RESULTS MET 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 REQUIREMENT.

    Description of Event or Problem · 1

    PHYSICIAN NOTICED WHEN OPENING PACKAGE THAT THE ADVANCED NEURON DELIVERY CATHETER HAD ITS TIP FLATTENED. THIS WAS DURING PREP FOR THE CASE AND NO PT CONTACT HAD OCCURRED. THE CATHETER WAS REPLACED WITH ANOTHER OF THE SAME MODEL AND THE CASE PROCESSED WITHOUT INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADVANCED NEURON DELIVERY CATHETER 070 PERCUTANEOUS CATHETER DQY PENUMBRA, INC. 15336

    Patients

    Seq Age Sex Outcome Treatment
    1