BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VELOCITY RX

    MDR report key: 362485 · Received November 29, 2001

    Report

    Report Number
    362485
    Event Type
    Malfunction
    Date Received
    November 29, 2001
    Date of Event
    October 29, 2001
    Report Date
    November 7, 2001
    Manufacturer
    CORDIS. A J & J CO.
    Product Code
    MAF
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MO, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    ON EVENT DATE, THE PT WAS RETURNED TO THE CATH LAB FOR A STENT OF THE 70% STENOSIS IN THE PROXIMAL LAD. THE LAD WAS VISUALIZED AS IT WAS TWO DAYS EARLIER. THE STENOSIS WAS BALLOONED SUCCESSFULLY WITH PICC. A 3.5MM X 13MM VELOCITY RX STENT WAS POSITIONED WITHIN THE STENOSIS AND STENT SINGLE PREPPED. SEVERAL ATTEMPTS AT INFLATION PRODUCED AND NO PRESSURE ON THE INDEFLATOR DIAL. THE INDEFLATOR PULLED NEGATIVE AGAIN. THE STENT AND STENT CATHETER WERE PULLED BACK AND IT BECAME EVIDENT THE STENT WAS NO LONGER ATTACHED TO THE ENTIRE CATHETER JUST PART OF IT. THE STENT CATHETER WAS WITHDRAWN AND FOUND TO HAVE A BROKEN (FRACTURED) SHAFT. THE STENT AND BROKEN CATHETER WERE REMOVED FROM THE PT BY WITHDRAWING THE ENTIRE GUIDEWIRE SYSTEM, INCLUDING GUIDE CATHETER. THE LAD WAS THEN RECANNULATED AND WIRED USING A NEW (UNKNONW) GUIDE CATH, GUIDE WIRE, AND STENT, WITHOUT PROBLEMS. THERE WAS NO APPARENT INJURY TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    53715 VELOCITY RX BALLOON EXPANDABLE STENT SYSTEM MAF CORDIS. A J & J CO. * 40201088

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Other SUCCESSFULLY AFTER THE 1ST STENT SYSTEM FAILED,| ANOTHER (UNKNOWN) STENT SYSTEM WAS IMPLANTED| DUE TO THE BROKEN CATHETER SHAFT, IN 2001.