BEUDAMED
    FDA Adverse Event Summary report: N

    STEALTH 360

    MDR report key: 3071217 · Received April 15, 2013

    Report

    Report Number
    3071217
    Date Received
    April 15, 2013
    Date of Event
    March 28, 2013
    Report Date
    April 5, 2013
    Manufacturer
    CARDIOVASCULAR SYSTEMS INC.
    Product Code
    MCW
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TX, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT UNDERWENT AN AORTOGRAM, BILATERAL ILIAC ARTERY RUNOFF FOR COMPLETE OCCLUSION OF THE RIGHT ILIAC ARTERY. DURING THE BILATERAL ILIAC ARTERY PERCUTANEOUS ANGIOPLASTY THERE WAS A RETAINED FOREIGN OBJECT TO THE BRANCH OF THE LEFT INTERNAL ILIAC ARTERY. THE TIP OF A CSI 1.50MM ATHERECTOMY CATHETER BROKE OFF WHEN THE MD ATTEMPTED TO REMOVE THE DEVICE. THE MD ATTEMPTED TO REMOVE THE CATHETER TIP WITH A SNARE DEVICE. AFTER MULTIPLE ATTEMPTS THEY ABORTED RETRIEVAL ATTEMPTS. PT WAS TO HAVE BILATERAL ILIAC ATHERECTOMY, WAS GOING TO RECEIVE STENTS AS WELL. WILL RETURN NEXT WEEK FOR BILATERAL ILIAC STENT PLACEMENT. CARDIOVASCULAR SURGEON WAS CONSULTED. REVIEW OF FILMS SHOW THE CATHETER LODGED BETWEEN THE 2ND AND 3RD LEVEL BRANCH OF THE LEFT HYPOGASTRIC ARTERY. SURGEON FELT THERE WAS MORE RISK IN GOING IN TO RETRIEVE THE TIP, FELT THERE TO BE NO CLINICAL CONSEQUENCE OF TIP WHERE IT IS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    161004 STEALTH 360 NONE MCW CARDIOVASCULAR SYSTEMS INC. PRD-SC30-200 74267

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR