BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEURON DELIVERY CATHETER 053

    MDR report key: 1830844 · Received March 15, 2010

    Report

    Report Number
    3005168196-2010-00256
    Event Type
    Malfunction
    Date Received
    March 15, 2010
    Date of Event
    November 26, 2008
    Report Date
    November 26, 2008
    Manufacturer
    PENUMBRA, INC.
    Product Code
    DQY
    PMA / PMN Number
    K070970
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DHR FOR THIS MFG LOT HAS BEEN REVIEWED. THIS MDR IS BEING FILED AS PART OF THE REMEDIATION ACTION TAKEN AS PER PENUMBRA FEBRUARY 2010 UPDATE TO THE FDA WARNING LETTER DATED DECEMBER 31, 2009. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS COMPLETED ON PART #1147-02 (LOT # L13360) AND SUB-ASSEMBLY PN0918-02 (LOT# L13204). ALL APPROPRIATE INSPECTIONS WERE COMPLETED PER PROCESS MONITORING REQUIREMENTS OR 100% INSPECTIONS WHERE REQUIRED. THE DHR REVIEW OF FINAL ASSEMBLY (LOT# L13360) INDICATED THAT 100% INSPECTION OF THE DEVICES RESULTED IN (B)(4) REJECT. THE DHR REVIEW OF SUB-ASSEMBLY PN0918-02 (LOT# L13204) INDICATED THAT 100% INSPECTION OF THE DEVICES RESULTED IN (B)(4) REJECTS. THE LOT WAS ASSOCIATED WITH (B)(4) FOR PARTICULATES (FIBER) FOUND IN THE DISTAL SECTION WHICH WAS DETERMINED TO BE ASSOCIATED WITH THE COATING PROCESS. A SCAR WAS ISSUED TO (B)(4) TO DETERMINE THE ROOT CAUSE OF THE PROBLEM AND IT WAS CONCLUDED THAT THIS HIGH LEVEL OF FM IS RELATED TO THE CLEANING OF THE CATHETERS BEFORE THE COATING PROCESS, IF THE CATHETERS ARE NOT CLEAN, THE FM ON THE CATHETERS GOES INTO THE COATING SOLUTION AND BECOME EMBEDDED IN THE PRODUCT DURING THE COATING PROCESS. ONE HUNDRED PERCENT VISUAL INSPECTION WAS PERFORMED TO SEGREGATE THE BAD UNITS AND AS A RESULT 105 OUT OF 169 UNITS WERE ACCEPTED. IN ADDITION, ALL DESTRUCTIVE TESTING WAS COMPLETED PER REQUIRED PROCESS MONITORING REQUIREMENTS AND RESULTS MET SPECIFICATION. VISUAL FAILURE COULD NOT BE ATTRIBUTED TO THE INCIDENT AS 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 MFG PROCESS. THE PARTS RELEASED IN THIS LOT MET PROCESS REQUIREMENT.

    Description of Event or Problem · 1

    BEFORE OPENING THE PACKAGE, IT WAS FOUND THAT THE CATHETER WAS FLATTENED AT THE DISTAL FLEXIBLE END.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEURON DELIVERY CATHETER 053 PERCUTANEOUS CATHETER DQY PENUMBRA, INC. F13360

    Patients

    Seq Age Sex Outcome Treatment
    1