BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MONORAIL

    MDR report key: 5252980 · Received November 22, 2015

    Report

    Report Number
    MW5058145
    Event Type
    Injury
    Date Received
    November 22, 2015
    Date of Event
    November 12, 2015
    Report Date
    November 23, 2015
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    NIQ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OH, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2015 1817 BY RISK, RDE: PATIENT IN CATH LAB FOR DIAGNOSTIC CARDIAC CATH THEN PCI OF RCA. BMW WIRE PLACED IN RCA. RCA BALLOONED AND REMOVED. A 6 FRENCH GUIDE LINER PLACED. STENT CATHETER INSERTED IN RCA. STENT DISLODGED FROM CATHETER IN RCA OSTIUM. STENT DRAGGED FROM RCA OSTIUM TO RIGHT RADIAL ARTERY. UNABLE TO REMOVE STENT WITH SNARE. SURGERY CONSULTED. CUT DOWN PERFORMED AND STENT REMOVED FROM RADIAL ARTERY BY SURGEON. SURGERY SUCCESSFUL. PATIENT SENT TO ICU.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    772331 MONORAIL EVEROLIMUS-ELUTING PLANTINUM CHROMIUM CORONARY STENT SYSTEM NIQ BOSTON SCIENTIFIC M7493952828400 18374107

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Required Intervention