BEUDAMED
    FDA Adverse Event Other Summary report: N

    OVER-THE-WIRE PERIPHERAL LASER CATHETER

    MDR report key: 1381648 · Received January 30, 2009

    Report

    Report Number
    1721279-2009-00002
    Event Type
    Other
    Date Received
    January 30, 2009
    Date of Event
    January 9, 2009
    Report Date
    January 29, 2009
    Manufacturer
    SPECTRANETICS CORP.
    Product Code
    GEX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    CLINICAL HISTORY: PT IS ADMITTED FOR A RIGHT-SIDED, CTO SFA. PROCEDURE: DR (B)(6) BEGAN THE CASE BY UTILIZING A 1.7MM OTW AND LASED FOR APPROXIMATELY 25 MINUTES, NEEDING AT THAT POINT TO UP SIZE TO A 2.3MM OTW. DURING LASING WITH THE 2.3MM, IT BECAME APPARENT THE PATIENT'S SFA HAD BEEN PERFORATED WITH ACTIVE EXTRAVASATION INTO THE PT'S RIGHT THIGH. AT THIS POINT, DR (B)(6) BALLOONED AND STENTED THE PERFORATION WITH A POSITIVE RESULT. PT OUTCOME: PT WAS TRANSFERRED TO THE ICU IN CRITICAL CONDITION. PT RECEIVED BLOOD PRODUCTS DUE TO A LOW "CRIT" LEVEL. IT WAS UNKNOWN IF THE LOW LEVELS WERE A DIRECT RESULT OF THE LOSS OF BLOOD DURING THE PERFORATION. THE PT WAS REPORTED TO BE IN POOR HEALTH PRIOR TO THE SURGICAL CASE. FAILURE ANALYSIS: THERE IS NO INDICATION AT THIS TIME, THE EVENT WAS CAUSED BY THE MALFUNCTION OF THE SPNC DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OVER-THE-WIRE PERIPHERAL LASER CATHETER 1.7 MM OTW / 2.3 OTW GEX SPECTRANETICS CORP. 417-152 / 423-001

    Patients

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