BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TURBO ELITE LASER ABLATION CATHETER

    MDR report key: 2801917 · Received October 23, 2012

    Report

    Report Number
    1721279-2012-00136
    Event Type
    Injury
    Date Received
    October 23, 2012
    Date of Event
    August 31, 2012
    Report Date
    October 1, 2012
    Manufacturer
    SPECTRANETICS CORPORATION
    Product Code
    MCW
    PMA / PMN Number
    K060012
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THIS WAS A VASCULAR INTERVENTION CASE CONDUCTED IN THE CARDIAC CATH LAB TO ATTEMPT RETURN BLOOD FLOW TO THE PATIENT'S LEFT SFA. THE PATIENT HAD A 300MM, SUBACUTE, IN-STENT (VIABAHN COVERED STENTS; 16MTHS OLD) CTO OF THE LEFT SFA. THE PHYSICIAN CHOSE TO USE BOTH THE 2.0 TURBO ELITE (TE) AND TURBO TANDEM (TT) ON THIS LESION. THE PHYSICIAN WAS ADVISED THAT THESE TWO PRODUCTS WERE NOT INDICATED FOR THIS PROCEDURE AND USING THEM WOULD BE OFF-LABEL. THE PHYSICIAN PLACED BOTH A TERUMO 7F SHEATH AND A DISTAL EMBOLI PROTECTION DEVICE INTO THE SFA. AFTER LASING FOR 7 MINUTES DOWN THE ENTIRE LENGTH OF THE LESION NO LUMEN WAS ACHIEVED. THE TT WAS THEN USED TO MAKE ONE PASS DOWN THE LESION, AGAIN UNSUCCESSFULLY. THE DISTAL EMBOLI PROTECTION WAS REMOVED AND THE PATIENT WAS TREATED WITH A BALLOON, STENT AND TPA. THE PATIENT WAS NOT HARMED BY THE OFF-LABEL USE OF THE TE AND TT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TURBO ELITE LASER ABLATION CATHETER 2.0 TURBO ELITE MCW SPECTRANETICS CORPORATION 420-006 F12G20B

    Patients

    Seq Age Sex Outcome Treatment
    1 Other DISTAL EMBOLIZATION PROTECTION DEVICE| TURBO TANDEM| 7F TERUMO SHEATH| CVX-300 EXCIMER LASER SYSTEM| VIABAHN STENT(S)