BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEURON MAX 6F 088

    MDR report key: 3955376 · Received July 24, 2014

    Report

    Report Number
    3005168196-2014-00477
    Event Type
    Malfunction
    Date Received
    July 24, 2014
    Date of Event
    June 23, 2014
    Report Date
    June 24, 2014
    Manufacturer
    PENUMBRA, INC.
    Product Code
    DQY
    PMA / PMN Number
    K111380
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    RADIOLOGIC TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    RESULT: THE NEURON MAX 088 LONG SHEATH IS KINKED APPROXIMATELY 14.5 CM FROM THE DISTAL TIP. CONCLUSION: THE COMPLAINT HAS BEEN EVALUATED. THE COMPLAINT INDICATES THAT THE NEURON MAX 088 LONG SHEATH KINKED DURING USE CAUSING DAMAGE TO THREE NEURON DELIVERY CATHETERS. EVALUATION OF THE RETURNED DEVICES REVEALED ONE NEURON MAX WITH NO DAMAGE AND A SECOND NEURON MAX KINKED IN THE DISTAL SHAFT. TWO NEURON DELIVERY CATHETERS WERE RETURNED, BOTH WITH DAMAGE IN THE DISTAL SHAFT. THE INCONSISTENCIES BETWEEN WHAT WAS DESCRIBED IN THE COMPLAINT AND WHAT RETURNED MAKE DETERMINING THE ROOT CAUSE DIFFICULT HOWEVER, IT APPEARS THAT ONE OF THE NEURON MAX LONG SHEATHS KINKED WHEN THE NEURON DELIVERY CATHETER WAS INSIDE THE SHEATH. ONCE THIS KINK OCCURRED, ANOTHER DEVICE WOULD NOT HAVE BEEN ABLE TO BE ADVANCED THROUGH THE CATHETER THEREFORE; IT IS UNKNOWN HOW THE SECOND DELIVERY CATHETER WAS DAMAGED. THESE CATHETERS ARE 100% VISUALLY INSPECTED FOR DAMAGE DURING PROCESSING. THE DAMAGE SEEN MAY HAVE BEEN DUE TO MISHANDLING OF THE DEVICES DURING PREPARATION OR WHEN ATTEMPTING TO PLACE THE DEVICES DURING THE PROCEDURE. THIS MDR IS ASSOCIATED WITH MDR 3005168196-2014-00476, 00478, AND 00479.

    Description of Event or Problem · 1

    THE PATIENT WAS UNDERGOING A MEDICAL PROCEDURE USING A NEURON MAX 6F 088 AND A NEURON 6F 070 DELIVERY CATHETER. DURING THE PROCEDURE, A NEURON MAX, A NEURON DELIVERY CATHETER 070, AND ANOTHER NEURON CATHETER BECAME KINKED. THERE WAS NO REPORT OF AN ADVERSE EFFECT ON THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    433657 NEURON MAX 6F 088 DQY DQY PENUMBRA, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR