BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEURON DELIVERY CATHETER 053

    MDR report key: 2882830 · Received December 20, 2012

    Report

    Report Number
    3005168196-2012-00439
    Event Type
    Malfunction
    Date Received
    December 20, 2012
    Date of Event
    November 14, 2012
    Report Date
    November 21, 2012
    Manufacturer
    PENUMBRA, INC.
    Product Code
    DQY
    PMA / PMN Number
    K070970
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE INVESTIGATION: RESULTS: THE CATHETER IS BROKEN JUST DISTAL OF THE ID BAND ON THE PROXIMAL SHAFT OF THE CATHETER. THE SURFACE OF THE BREAK SITE SHOWS STRETCHING AND MATERIAL DEFORMATION. THERE IS A KINK IN THE CATHETER 35.5 CM DISTAL OF THE BREAK SITE. CONCLUSION: THE BREAK NOTED IN THE COMPLAINT IS CONFIRMED. THE CAUSE OF THE BREAK CANNOT BE DIRECTLY DETERMINED BUT THE DEFORMATION OF THE SHAFT MATERIAL AT THE BREAK SITE SUGGESTS THAT SIGNIFICANT EXTERNAL FORCE WAS APPLIED TO BREAK THE CATHETER. THIS KIND OF BREAK OFTEN OCCURS IF THE HUB OF THE CATHETER IS TORQUED AND BENT DURING MANIPULATION IN THE PATIENT. THE MANUFACTURING RECORDS FOR THIS LOT WERE REVIEWED AND DID NOT REVEAL ANY OUTSTANDING DISCREPANCIES, QUALITY, OR DESIGN CONCERNS.

    Description of Event or Problem · 1

    THE PATIENT WAS UNDERGOING A GLUE PROCEDURE WITH NBCA FOR AN AVM IN THE BRAIN. THE PHYSICIAN WAS USING THE NEURON 053 AS A GUIDE CATHETER AND HAD A MAGIC MICROCATHETER TO DELIVER THE GLUE. THE CATHETER WAS ADVANCED INTO THE RIGHT VERTEBRAL ARTERY TO THE C2 LEVEL. THE NEURON 053 BROKE NEAR THE HUB DURING THE PROCEDURE AND NEEDED TO BE PULLED OUT AND REPLACED. THE PROCEDURE WAS COMPLETED WITHOUT INCIDENT TO THE PATIENT. PATIENT INFORMATION WAS REQUESTED BUT THE PHYSICIAN CLAIMED HE WOULD NOT DISCLOSE THE INFORMATION BECAUSE OF HIPPA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEURON DELIVERY CATHETER 053 DQY DQY PENUMBRA, INC. F23959

    Patients

    Seq Age Sex Outcome Treatment
    1