BEUDAMED
    FDA Adverse Event Other Summary report: N

    2.5MM OVER-THE-WIRE TURBO ELITE

    MDR report key: 1342430 · Received March 9, 2009

    Report

    Report Number
    1721279-2009-00009
    Event Type
    Other
    Date Received
    March 9, 2009
    Date of Event
    February 8, 2009
    Report Date
    February 8, 2009
    Manufacturer
    SPECTRANETICS CORP.
    Product Code
    GEX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    CLINICAL HISTORY: DIFFUSE THROMBUS OF THE SFA. PROCEDURE: MD WAS ATTEMPTING A THROMBECTOMY OF THE PT'S SFA. A 2.5MM TE CATHETER MADE THREE PASSES AT 60/40, 60/60 AND 60/80 WITH EMBOLIC PROTECTION USED WITH NO FLOW AFFECT POST LASING. AFTER THE MD HAD REMOVED THE EMBOLI SHIELD, THE DEVICE WAS FILLED WITH "CHARRED MATERIAL AND POST REMOVAL THROMBUS WAS THROUGHOUT THE VESSEL." THROMBUS ASPIRATION WAS ATTEMPTED WITH SOME SUCCESS, BUT DISTAL FLOW REMAINED COMPROMISED. PATIENT STATUS: DISTAL EMBOLIZATION AND THROMBUS THROUGHOUT VESSEL. NO OTHER INFORMATION AVAILABLE AT THIS TIME. FAILURE ANALYSIS: THE DEVICE IS CURRENTLY BEING INVESTIGATED. THE FINAL INVESTIGATION REPORT WILL BE A FOLLOW-UP SUBMISSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 2.5MM OVER-THE-WIRE TURBO ELITE 2.5 OTW TE GEX SPECTRANETICS CORP. 423-001 F08K08A

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention SPECTRANETICS CVX-300 LASER