BEUDAMED
    FDA Adverse Event Other Summary report: N

    NEURON SELECT CATHETER 053

    MDR report key: 2625555 · Received September 30, 2009

    Report

    Report Number
    3005168196-2009-00063
    Event Type
    Other
    Date Received
    September 30, 2009
    Date of Event
    August 29, 2007
    Report Date
    September 28, 2009
    Manufacturer
    PENUMBRA, INC.
    Product Code
    DQY
    PMA / PMN Number
    K082290
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSION: AS PER FDA FEEDBACK OF 08/28/2009, PHYSICIAN FEEDBACK OF THIS SORT MUST BE REPORTED. THE DHR FOR THIS MFG LOT HAS BEEN REVIEWED AND THAT REVIEW. INCIDENT # (B)(4): PART #1044.A. SA, NEURON SELECT CATHETER, SIMMONS SHAPE. LOT #F11635 (SAME AS L11635). A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS COMPLETED ON PART #1045.A, (MFG LOT # L11635). ALL APPROPRIATE INSPECTIONS WERE COMPLETED PER PROCESS MONITORING REQUIREMENTS OR 100% INSPECTIONS WERE REQUIRED. THE PARTS RELEASED IN THIS LOT MET PROCESS REQUIREMENT. IN ADDITION, ALL DESTRUCTIVE TESTING WAS COMPLETED PER PROCESS MONITORING REQUIREMENTS AND RESULTS MET SPECIFICATION FOR THE TENSILE STRENGTH. THE LOT WAS ASSOCIATED WITH DA (B)(4) IN ORDER TO OVER-LABEL AT RISK SPECIFIC NEURON SELECT CATHETER LOTS IN ANTICIPATION OF 3 YEARS SHELF LIFE.

    Description of Event or Problem · 1

    REMEDIATION-PHYSICIAN EVALUATION: DURING THE RE-TREATMENT OF AN ANTERIOR COMMUNICATING ANEURYSM, THE PHYSICIAN EXPRESSED FRUSTRATION WITH THE SELECT CATHETER, REPORTING THAT IT COULD NOT ACCESS THE VESSELS NEEDED TO TREAT THIS CASE. THE PROCEDURE WAS BRIEFLY DELAYED WHILE A DIFFERENT MANUFACTURER'S GUIDE WIRE WAS USED TO ACCESS THE NECESSARY VESSELS. THE PROCEDURE WAS COMPLETED WITH NO ADVERSE EFFECTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEURON SELECT CATHETER 053 PERCUTANEOUS CATHETER DQY PENUMBRA, INC. F11635

    Patients

    Seq Age Sex Outcome Treatment
    1