BEUDAMED
    FDA Adverse Event Death Summary report: N

    SPECTRANETICS TIGHTRAIL ROTATING DILATOR SHEATH

    MDR report key: 5486912 · Received March 8, 2016

    Report

    Report Number
    1721279-2016-00033
    Event Type
    Death
    Date Received
    March 8, 2016
    Date of Event
    February 17, 2016
    Report Date
    February 17, 2016
    Manufacturer
    SPECTRANETICS
    Product Code
    DRE
    PMA / PMN Number
    K140047
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CORRECTION RELATED TO MDR #1721279-2016-00032 AND MDR #1721279-2016-00030.

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE LEAD AND SUTURE MATERIAL WERE TIGHT TO THE ID OF THE DEVICE. THIS DEVICE WAS USED OVER A MDT SPRINT QUATRO ICD LEAD. AN INTERFERENCE WOULD BE POSSIBLE BASED ON THE LEAD SPECIFICATIONS COMBINED WITH THE ADDITION TO LEAD PROFILE WITH SUTURE MATERIAL. THIS WAS CONFIRMED THROUGH X-RAY OF THE DEVICE AND FUNCTIONAL TESTING OF THE LEAD THROUGH THE LUMEN OF THE TIGHTRAIL WHEN THE SUTURE WAS REMOVED FROM THE LEAD. ID OF THE TIGHTRAIL MEETS SPECIFICATION IN ACCEPTING THE LEAD.

    Description of Event or Problem · 1

    LEAD EXTRACTION PROCEDURE FOR NON-FUNCTIONING LEADS IN THE RV AND RA. A 14FR GLIDELIGHT SELECTED FOR REMOVAL OF THE RV LEAD. LEAD ON LEAD BINDING WAS NOTED. A TEAR IN THE SUBCLAVIAN VEIN OCCURRED. THE RA LEAD EXTRACTION WAS ATTEMPTED USING A TIGHTRAIL DEVICE. TIGHTRAIL WAS ROTATED AND PULLED, THE DISTAL END OF THE TIGHTRAIL EXITED THE INSERTION SITE. THE PHYSICIAN CUT THE LEAD LEAVING HALF IN THE DEVICE AND HALF IN THE PATIENT. PULLING ON THE RV LEAD A TEAR IN THE TRICUSPID VALVE OCCURRED. IT IS BELIEVED THE LEAD WAS ATTACHED TO THE PAPILLARY MUSCLE, PULLING ON THE LEAD TORE THE MUSCLE. REPAIRS WERE DONE AT DIFFERENT TIMES. THE PATIENT WAS PLACED ON BYPASS AND UNDERWENT A TRICUSPID VALVE REPLACEMENT. THE SUBCLAVIAN VEIN WAS REPAIRED BY IR VIA FEMORAL APPROACH USING A STENT GRAFT. DURING THE VALVE REPAIR, THE EXTRACTOR WAS PLACING HER FINGER ON THE HOLE IN THE SUBCLAVIAN VEIN TO STOP BLEEDING. POSTOPERATIVE, THE PATIENT WAS PLACED ON A RIGHT VENTRICULAR ASSIST DEVICE. THE PATIENT EXPIRED IN THE ICU, BELIEVED DUE TO POOR SURGICAL REPAIR AND FAILURE OF THE RIGHT VENTRICULAR ASSIST DEVICE. THIS REPORT IS FOR THE TIGHTRAIL. SEE REPORTS 1721279-2016-00031 FOR GLIDELIGHT AND 1921279-2016-00032. FOR LLD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    142495 SPECTRANETICS TIGHTRAIL ROTATING DILATOR SHEATH TIGHTRAIL DRE SPECTRANETICS 545-511 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Death