BEUDAMED
    FDA Adverse Event Death Summary report: N

    SPECTRANETICS TURBO ELITE LASER ABLATION CATHETER

    MDR report key: 5531990 · Received March 29, 2016

    Report

    Report Number
    1721279-2016-00042
    Event Type
    Death
    Date Received
    March 29, 2016
    Date of Event
    March 14, 2016
    Report Date
    March 14, 2016
    Manufacturer
    SPECTRANETICS
    Product Code
    MCW
    PMA / PMN Number
    K140775
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    DEVICE 510K NUMBER HAS BEEN CORRECTED TO REFLECT THE MOST CURRENT AND UP TO DATE NUMBER, AS OF THE DATE OF THE INITIAL REPORT.

    Additional Manufacturer Narrative · 1

    UPDATED TO INCLUDE DEVICE AND PATIENT CODES.

    Description of Event or Problem · 1

    A (B)(6) Y/O FEMALE WAS UNDERGOING A PERIPHERAL INTERVENTION OF THE RIGHT SFA. THE PATIENT HAD A HISTORY OF MULTIPLE PERIPHERAL AND AORTIC BYPASSES. AFTER PLACEMENT OF A COOK ANSEL GUIDING SHEATH AND ANGIOGRAPHY, A CTO WAS IDENTIFIED IN THE PROXIMAL SFA AND RECONSTITUTED ABOVE HUNTERS CANAL. HEPARIN WAS GIVEN. LESION WAS A SOFT CTO WHICH THE PHYSICIAN CROSSED WITHOUT DIFFICULTY. A 1.7 OTW TURBO ELITE WAS INTRODUCED AND LASERING COMMENCED. FOUR PASSES WERE COMPLETED WITH THE LASER AT VARYING SETTINGS; TOTAL LASING TIME WAS JUST OVER 4 MINUTES. ALL IFU AND PROTOCOLS WERE FOLLOWED DURING THE LASER PROCEDURE. AFTER LASERING A COOK 6X100 BALLOON WAS BEING PREPPED FOR USE IN THE PATIENT. THE PATIENT STATED SHE WASN'T FEELING WELL, WAS NAUSEOUS AND HER BP STARTED DROPPING. 911 WAS CALLED AND AT 0929 CHEST COMPRESSIONS AND AIRWAY MANAGEMENT WERE STARTED. ATTEMPTS WERE MADE TO INTUBATE WITHOUT SUCCESS. EMS ARRIVED AND ATTEMPTED TO STABILIZE THE PATIENT BUT WERE UNSUCCESSFUL AND THE PATIENT WAS TRANSPORTED VIA AMBULANCE TO THE HOSPITAL. THE PATIENT HAD BEEN PLACED ON LIFE SUPPORT AND ON (B)(6) 2016 THE FAMILY CHOSE TO REMOVE LIFE SUPPORT AND THE PATIENT DIED. SPNC REPRESENTATIVE CONTACTED FOR FOLLOW-UP, STATES CAUSE OF DEATH IS UNKNOWN, HOWEVER THE PHYSICIAN DOES NOT BELIEVE THAT USE OF THE LASER CAUSED THE AE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    189286 SPECTRANETICS TURBO ELITE LASER ABLATION CATHETER TURBO ELITE MCW SPECTRANETICS 417-152 FAZ16A20A

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Death