BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TURBO-TANDEM LASER GUIDE/ATHERECTOMY CATHETER

    MDR report key: 1994370 · Received January 14, 2011

    Report

    Report Number
    1721279-2010-00090
    Event Type
    Malfunction
    Date Received
    January 14, 2011
    Date of Event
    December 13, 2010
    Report Date
    December 15, 2010
    Manufacturer
    SPECTRANETICS CORP.
    Product Code
    GEX
    PMA / PMN Number
    K094036
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE AND RETRIEVED PIECE ARE NOT AVAILABLE FOR RETURN TO SPECTRANETICS AT THIS TIME. THE DEVICE IS IN THE POSSESSION OF THE RISK MGMT OFFICER AT (B)(6). AN INTERNAL LHR REVIEW WAS CONDUCTED AND SHOWED NO ISSUES OR NON-CONFORMANCES.

    Description of Event or Problem · 1

    PT PRESENTED WITH A COMPLETELY OCCLUDED, PREVIOUSLY STENTED SUPERFICIAL ARTERY APPROXIMATELY 70 MM IN LENGTH, OCCLUSION WAS LOCATED IN DISTAL PORTION OF THE ARTERY. A 2.0 MM RAPID EXCHANGE TURBO ELITE WAS ADVANCED TROUGH THE LESION AT SETTINGS OF 60 X 80. A SMALL CHANNEL WITH BRISK FLOW WAS NOTED. THE 2.0 MM TURBO ELITE WAS REMOVED AND A TT DEVICE WAS PLACED OVER AN ABBOTT MIRACLE BROTHERS THREE WIRE. THE TT WAS CALIBRATED AND SET TO THE SETTINGS OF 60 X 80. THE TT WAS ADVANCED THROUGH THE LESION TWO TIMES IN A QUADRANT FASHION WHEN IT WAS NOTED THAT THE MOST DISTAL CONE AND MARKER OF THE TT DEVICE SEEMED TO HAVE PROLAPSED UPON ITSELF, IN AN ORIENTATION TOWARD THE RAMP AND LASER FIBER. THE TT DEVICE WAS PROMPTLY REMOVED. UPON INSPECTION OF THE REMOVED DEVICE IT WAS NOTED BY THE PHYSICIAN THAT THE DISTAL END OF THE TT WAS DAMAGED. ANGIOGRAPHY CONFIRMED THAT THE MOST DISTAL MARKER OF THE TT DEVICE HAD SEPARATED FROM THE DEVICE AND REMAINED IN THE PT SUPERFICIAL FEMORAL ARTERY. THE PHYSICIAN WAS ABLE TO REMOVE THE DISTAL MARKER TYPE AFTER A GREAT DEAL OF EFFORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TURBO-TANDEM LASER GUIDE/ATHERECTOMY CATHETER TURBO-TANDEM (TT) GEX SPECTRANETICS CORP. 472-110 FBX10G28B

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention CVX-300 EXCIMER LASER (SERIAL# (B)(4))| TURBO ELITE 2.0 RX (420-159/ UNK SERIAL #)