BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEURON DELIVERY CATHETER

    MDR report key: 4854367 · Received June 18, 2015

    Report

    Report Number
    3005168196-2015-00598
    Event Type
    Malfunction
    Date Received
    June 18, 2015
    Date of Event
    May 18, 2015
    Report Date
    May 19, 2015
    Manufacturer
    PENUMBRA, INC.
    Product Code
    DQY
    PMA / PMN Number
    K082290
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION RECEIVED ON 8/09/2016. RESULTS: THE DISTAL SHAFT OF THE NEURON 070 WAS OVALIZED APPROXIMATELY 2.0 AND 4.0 CM FROM THE DISTAL TIP. CONCLUSIONS: EVALUATION OF THE RETURNED DEVICE CONFIRMED THE DAMAGE REPORTED IN THE COMPLAINT. THE NEURON 070 DISTAL SHAFT WAS OVALIZED IN TWO LOCATIONS. THIS TYPE OF DAMAGE TYPICALLY OCCURS DUE TO IMPROPER HANDLING DURING REMOVAL FROM THE PACKAGING. IF FORCE IS APPLIED ALONG THE CATHETER SHAFT, IT IS LIKELY THAT DAMAGE WILL OCCUR. THESE DEVICES ARE 100% VISUALLY INSPECTED FOR DAMAGE DURING PROCESS INSPECTION. THE MANUFACTURING RECORDS FOR THIS LOT WERE REVIEWED AND DID NOT REVEAL ANY OUTSTANDING DISCREPANCIES, DESIGN, OR QUALITY CONCERNS.

    Additional Manufacturer Narrative · 1

    RESULT: THE DISTAL SHAFT OF THE NEURON 070 WAS OVALIZED APPROXIMATELY 2.0 AND 4.0 CM FROM THE DISTAL TIP. CONCLUSION: THE COMPLAINT HAS BEEN EVALUATED. THE COMPLAINT INDICATED THAT THE PATIENT WAS UNDERGOING A MEDICAL PROCEDURE USING A NEURON 6F 070 DELIVERY CATHETER. UPON REMOVAL FROM THE PACKAGING, THE NEURON DELIVERY CATHETER WAS FOUND OVALIZED NEAR THE DISTAL TIP AND WAS NOT USED. EVALUATION OF THE RETURNED DEVICE CONFIRMED THE DAMAGE REPORTED IN THE COMPLAINT. THE NEURON 070 DISTAL SHAFT WAS OVALIZED IN TWO LOCATIONS. THIS TYPE OF DAMAGE TYPICALLY OCCURS DUE TO IMPROPER HANDLING DURING REMOVAL FROM THE PACKAGING. IF FORCE IS APPLIED ALONG THE CATHETER SHAFT, IT IS LIKELY THAT DAMAGE WILL OCCUR. THESE DEVICES ARE 100% VISUALLY INSPECTED FOR DAMAGE DURING PROCESS INSPECTION. THE MANUFACTURING RECORDS FOR THIS LOT WERE REVIEWED AND DID NOT REVEAL ANY OUTSTANDING DISCREPANCIES, DESIGN, OR QUALITY CONCERNS.

    Description of Event or Problem · 1

    THE PATIENT WAS UNDERGOING A MEDICAL PROCEDURE USING A NEURON 6F 070 DELIVERY CATHETER. UPON REMOVAL FROM THE PACKAGING, THE NEURON DELIVERY CATHETER WAS FOUND OVALIZED NEAR THE DISTAL TIP AND WAS NOT USED. THE PHYSICIAN USED A NEW NEURON TO COMPLETE THE PROCEDURE.

    Description of Event or Problem · 1

    THE PATIENT WAS UNDERGOING A MEDICAL PROCEDURE USING A NEURON 6F 070 DELIVERY CATHETER. UPON REMOVAL FROM THE PACKAGING, THE NEURON DELIVERY CATHETER WAS FOUND OVALIZED NEAR THE DISTAL TIP AND WAS NOT USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    396151 NEURON DELIVERY CATHETER DQY DQY PENUMBRA, INC. F62854

    Patients

    Seq Age Sex Outcome Treatment
    1