BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVANCECE

    MDR report key: 6092049 · Received November 10, 2016

    Report

    Report Number
    1220452-2016-00071
    Event Type
    Malfunction
    Date Received
    November 10, 2016
    Report Date
    October 13, 2016
    Manufacturer
    MEDTRONIC, INC
    Product Code
    DXE
    PMA / PMN Number
    K130536
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    PHYSICIAN REPORTED THAT THEY HAD CASES OF ADVANCE CE ASPIRATION CATHETERS WHERE THEY WERE SLIGHTLY FRAYED AND THE PHYSICIAN USED THEM. NO PATIENT INJURY REPORTED PLEASE NOTE THAT THIS DEVICE ADVANCE CE IS NOT MARKETED IN THE UNITED STATES; HOWEVER, THE DEVICE IS DEEMED THE SAME AS THE UNITED STATES MARKETED DEVICE EXPORT ADVANCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    744580 ADVANCECE CATHETER, EMBOLECTOMY DXE MEDTRONIC, INC

    Patients

    Seq Age Sex Outcome Treatment
    1