BEUDAMED
    FDA Adverse Event Other Summary report: N

    NEURON DELIVERY CATHETER 070

    MDR report key: 2624161 · Received September 29, 2009

    Report

    Report Number
    3005168196-2009-00057
    Event Type
    Other
    Date Received
    September 29, 2009
    Date of Event
    November 4, 2008
    Report Date
    September 28, 2009
    Manufacturer
    PENUMBRA, INC.
    Product Code
    DQY
    PMA / PMN Number
    K082290
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSION: AS PER FDA FEEDBACK OF (B)(4) 2009, THIS SORT OF PHYSICIAN EVALUATION FEEDBACK MUST BE REPORTED. THE DHR FOR THIS MANUFACTURING LOT HAS BEEN REVIEWED AND THAT REVIEW IS ATTACHED. INCIDENT # (B)(4). A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS COMPLETED ON PART # (B)(4) NEURON DELIVERY CATHETER 070 (95CM X 6 CM) SHAPED TIP, LOT NUMBER L13856. 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. NO OTHER ANOMALIES WERE FOUND WITH THIS LOT DUE TO THE MANUFACTURING PROCESS. THE PARTS RELEASED IN THIS LOT MET PROCESS REQUIREMENT.

    Description of Event or Problem · 1

    COULD NOT PLACE IN PETROUS SEGMENT BECAUSE VESSEL STARTED TO SPASM. WOULD HAVE PREFERRED 6/5 .053. PER SALES REPRESENTATIVE FOLLOW UP EMAIL: THE PROCEDURE DIDN'T GO THAT WELL BECAUSE THE PHYSICIAN TRIED PUSHING THE 070 INTO THE PETROUS WITH A 4FR GLIDE AND DEVELOPED SPASM. HE BACKED OFF AND DECIDED TO LEAVE THE 070 PRE-PETROUS. CASE WENT FINE, GREAT OUTCOME. HE SAID HE WOULD HAVE NORMALLY USED THE 053 BUT WILL USE THE 070.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEURON DELIVERY CATHETER 070 PERCUTANEOUS CATHETER DQY PENUMBRA, INC. F13856

    Patients

    Seq Age Sex Outcome Treatment
    1