BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXPRESS (R) SD RENAL/BILIARY

    MDR report key: 2230400 · Received September 1, 2011

    Report

    Report Number
    2134265-2011-03792
    Event Type
    Malfunction
    Date Received
    September 1, 2011
    Report Date
    August 8, 2011
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    FGE
    PMA / PMN Number
    K040027
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    RADIOLOGIC TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MANUFACTURER: 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 REPORTED THAT DURING A PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY TREATMENT PROCEDURE, THE STENT DISLODGED. THE 5.0X19X150CM EXP SD RENAL BILIARY SM WAS CHOSEN FOR THE STENTING PROCEDURE AND PRIOR TO INSERTING THE CATHETER INTO THE SHEATH, THE STENT DISLODGED FROM THE CATHETER OUTSIDE THE PATIENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT'S STATUS IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EXPRESS (R) SD RENAL/BILIARY CATHETER, BILIARY, DIAGNOSTIC FGE BOSTON SCIENTIFIC - MAPLE GROVE H74937912519150 0013872292

    Patients

    Seq Age Sex Outcome Treatment
    1