BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ION?

    MDR report key: 4192633 · Received October 22, 2014

    Report

    Report Number
    2134265-2014-06617
    Event Type
    Malfunction
    Date Received
    October 22, 2014
    Report Date
    October 7, 2014
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    P100023
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    DEVICE IS A COMBINATION PRODUCT. (B)(4). DEVICE EVALUATED BY MFR: THE DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS. UPON RECEIPT AND COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT THE CORRECT SIZE OF THE DEVICE WAS A 32MM X 3.00MM ION STENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SHAFT BREAK OCCURRED. AN ION STENT WAS SELECTED; HOWEVER, THE SHAFT SEPARATED. NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    672154 ION? CORONARY DRUG-ELUTING STENT NIQ BOSTON SCIENTIFIC - GALWAY H7493902432300

    Patients

    Seq Age Sex Outcome Treatment
    1