BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RADIUS CORONARY STENT DELIVERY SYSTEM

    MDR report key: 614012 · Received May 31, 2005

    Report

    Report Number
    6000093-2005-00640
    Event Type
    Malfunction
    Date Received
    May 31, 2005
    Date of Event
    April 29, 2005
    Report Date
    May 2, 2005
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    MAF
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DE, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    SAME CASE AS MFR'S #: 6000093-2005-00639 AND 6000093-2005-00641. IT WAS REPORTED THAT DURING A TREATMET PROCEDURE, THE SHAFT OF THE CATHETER BROKE. THE RADIUS STENT DELIVERY SYSTEM WAS ADVANCED AND DEPLOYED INTO THE TIBULAR PERONEAL ARTERY. IT IS NOTED THAT THIS IS AN OFF LABEL USE. THE SHAFT OF THE DELIVERY DEVICE KINKED AND SUBSEQUENTLY BROKE DURING WITHDRAWAL OUT OF THE GUIDE CATHETER. THE DELIVERY DEVICE, WIRE AND GUIDE CATHETER WERE REMOVED TOGETHER AS A UNIT. A SECOND RADIUS STENT DELIVERY SYSTEM WAS DEPLOYED NEAR THE FIRST STENT AND ALSO KINKED AND SUBSEQUENTLY BROKE UPON WITHDRAWAL OUT OF THE GUIDE CATHETER. THE DELIVERY SYSTEM, WIRE AND GUIDE CATHETER WERE REMOVED TOGETHER AS A UNIT. A THIRD RADIUS STENT WAS DEPLOYED AND ALSO KINKED AND SUBSEQUENTLY BROKE UPON WITHDRAWAL OUT OF THE GUIDE CATHETER. THE DELIVERY SYSTEM, WIRE AND GUIDE CATHETER WERE REMOVED TOGETHER AS A UNIT. NO PT INJURIES OR COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RADIUS CORONARY STENT DELIVERY SYSTEM SELF EXPANDING STENT WITH DELIVERY SYSTEM MAF BOSTON SCIENTIFIC RADIUS SOE 20MM X 3.5MM 5779922

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN