BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ICROSS¿

    MDR report key: 2802927 · Received October 24, 2012

    Report

    Report Number
    2134265-2012-06607
    Event Type
    Malfunction
    Date Received
    October 24, 2012
    Date of Event
    September 25, 2012
    Report Date
    September 25, 2012
    Manufacturer
    BOSTON SCIENTIFIC - FREMONT (CE)
    Product Code
    DQO
    PMA / PMN Number
    K063312
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATED BY MFR: IT IS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE BATCH HISTORY, HISTORICAL TRENDING, AND SIMILAR COMPLAINT TRENDING REVIEW FOR THE PRODUCT FAMILY WILL BE CONDUCTED. IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    SAME CASE AS MDR ID# 2134265-2012-06389. IT WAS REPORTED THAT DURING A STENTING TREATMENT PROCEDURE, REMOVAL DIFFICULTIES OCCURRED. THE 4.0 X 28 MM PROMUS ELEMENT STENT WAS DEPLOYED. THE ICROSS IVUS WAS BEING RETRACTED "WITH DIFFICULTY" AND STENT DEFORMATION WAS NOTED. ANOTHER STENT WAS DEPLOYED TO COVER THE DEFORMATION. THE CAUSE OF THE DEFORMATION WAS BELIEVED TO BE EITHER THE NON BSC GUIDE CATHETER, OR THE IVUS CATHETER. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ICROSS¿ CATHETER, INTRAVASCULAR, DIAGNOSTIC DQO BOSTON SCIENTIFIC - FREMONT (CE) H749518050

    Patients

    Seq Age Sex Outcome Treatment
    1