BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXPRESS® LD ILIAC / BILIARY

    MDR report key: 3592894 · Received January 27, 2014

    Report

    Report Number
    2134265-2014-00211
    Event Type
    Malfunction
    Date Received
    January 27, 2014
    Date of Event
    January 10, 2014
    Report Date
    January 10, 2014
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIO
    PMA / PMN Number
    P090003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (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 REPORTED THAT A SHAFT BREAK OCCURRED. A SUPER SHEATH WAS PLACED. AN EXPRESS-B-I LD 7.0X30X75CM STENT WAS INSERTED OVER A GUIDE WIRE; HOWEVER, THE SHEATH WAS KINKED AND THE SHAFT OF THE EXPRESS-B-I LD, PMTD, 7.0X30X75CM BROKE. THE SHEATH AND STENT CATHETER WERE REMOVED. A NEW SHEATH WAS INSERTED AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME EXPRESS-B-I LD, PMTD, 7.0X30X75CM STENT. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS OKAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    59717 EXPRESS® LD ILIAC / BILIARY STENT, ILIAC NIO BOSTON SCIENTIFIC - GALWAY H74938046730750 16369369

    Patients

    Seq Age Sex Outcome Treatment
    1