BEUDAMED
    FDA Adverse Event Death Summary report: N

    SPECTRANETICS TURBO ELITE LASER ABLATION CATHETER

    MDR report key: 6114612 · Received November 18, 2016

    Report

    Report Number
    1721279-2016-10170
    Event Type
    Death
    Date Received
    November 18, 2016
    Date of Event
    October 27, 2016
    Report Date
    October 27, 2016
    Manufacturer
    SPECTRANETICS
    Product Code
    MCW
    PMA / PMN Number
    K071227
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THIS (B)(6) MALE WAS BEING TREATED FOR CORONARY IN-STENT RE-STENOSIS OF APPROX. 195 CM., IN THE MID-LAD. THE PHYSICIAN SELECTED A SPECTRANETICS TURBO ELITE CATHETER FOR THE PROCEDURE. (THE TURBO ELITE HAS BEEN APPROVED TO TREAT RE-STENOTIC LESIONS OF THE PERIPHERAL VASCULATURE). THE PHYSICIAN HAD DIFFICULTY LASING OVER THE WIRE, THERE WAS PROLAPSE INTO A DIAGONAL VESSEL AND A PERFORATION OCCURRED. A PERICARDIAL WINDOW WAS PERFORMED AND THE INJURY REPAIRED. APPROX. 3 HOURS LATER, THE INJURY REOPENED WHICH NECESSITATED INTERVENTION. THE PATIENT DID NOT SURVIVE THE INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    763444 SPECTRANETICS TURBO ELITE LASER ABLATION CATHETER TURBO ELITE MCW SPECTRANETICS 410-154 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Death SPECTRANETICS ANGIOSCULPT PTCA| SPECTRANETICS CVX-300 LASER SYSTEM