BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECTRANETICS TIGHTRAIL ROTATING MECHANICAL DILATOR SHEATH

    MDR report key: 3930164 · Received July 11, 2014

    Report

    Report Number
    1721279-2014-00111
    Event Type
    Injury
    Date Received
    July 11, 2014
    Date of Event
    June 24, 2014
    Report Date
    June 24, 2014
    Manufacturer
    SPECTRANETICS CORPORATION
    Product Code
    DRE
    PMA / PMN Number
    K140047
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A VISUAL INSPECTION OF THE DEVICE WAS PERFORMED, TO INCLUDE MICROSCOPIC AND X-RAY EXAMINATION. NO ISSUES WERE FOUND WITH THE DEVICE AND NO MECHANICAL DEFECTS WERE FOUND. THE LLD WAS REMOVED FROM THE PROXIMAL END OF THE DEVICE WITHOUT FORCE. LIKEWISE THE LEAD AND SUTURES WERE REMOVED WITHOUT DIFFICULTY. A REMNANT OF THE TISSUE WAS OBSERVED WITHIN THE BLADE OPENING. THE REMNANT EASILY PASSED INTO THE LUMEN OF THE DEVICE AND WAS EXTRACTED FROM THE PROXIMAL END. THE LEAD INSULATION HAD A LONGITUDINAL SEPARATION THAT APPEARS TO BE JUST PROXIMAL OF THE AREA WHERE THE TISSUE WAS ATTACHED TO THE LEAD. IT IS UNCLEAR WHAT CAUSED THE BINDING BECAUSE THE LEAD, TISSUE AND LOCKING STYLET ALL SEPARATED FROM THE DEVICE EASILY. THE CONDITIONS LEADING TO THE BINDING OF THE LEAD WITHIN THE DEVICE CANNOT BE DETERMINED WITHOUT QUESTION. ALL THE COMPONENTS MOVED FREELY WITHIN THE DEVICE AT THE TIME OF EVALUATION. THE DEVICE REMAINS FUNCTIONAL. THE ROOT CAUSE OF THE BINDING OF THE LEAD MATERIALS WITHIN THE DEVICE WAS NOT APPARENT. (B)(4).

    Additional Manufacturer Narrative · 1

    THE UDI WAS LISTED INCORRECTLY ON THE PREVIOUS REPORT. THE CORRECTED UDI IS: (B)(4).

    Description of Event or Problem · 1

    THIS WAS A LEAD EXTRACTION CASE TO REMOVE ONE NON-FUNCTIONAL RV LEAD (SJM (B)(4), IMPLANTED 12 YEARS). THE LEAD WAS PREPPED WITH AN LLD-E AND EXTRACTION BEGAN WITH A 9F TIGHTRAIL. IT WAS NOTED THAT THE LEAD WAS HEAVILY SCARRED AND ADHERED TO THE SJM (B)(4) RA LEAD (NOT PLANNED FOR EXTRACTION). AFTER WORKING FOR 25 MINUTES ON THE LEAD, HE DECIDED TO UPSIZE TO AN 11F TIGHTRAIL. WHEN TRYING TO BACK OFF THE TIGHTRAIL, THE PHYSICIAN NOTICED THAT THE DEVICE WAS HUNG UP/CAUGHT ON THE LEAD. IN ORDER TO REMOVE THE DEVICE, THE PHYSICIAN HAD TO CUT THE LEAD (OUTSIDE OF THE PATIENT'S BODY) TO REMOVE THE DEVICE. THE PHYSICIAN SWITCHED TO A 14F GLIDELIGHT IN ORDER TO ENSURE HE WAS ABLE TO RETAIN ACCESS. HE WAS ABLE TO GET TO THE SAME SPOT AS HE WAS WITH THE 9F (INNOMINATE/SVC JUNCTION) AND THEN ULTIMATELY COULD NOT MAKE ANY PROGRESS WITH THE LASER SHEATH. HE DECIDED TO THEN SWITCH TO, AND SACRIFICE, THE ATRIAL LEAD. HE CONTINUED WITH THE 14F AND AFTER LITTLE PROGRESS UPSIZED TO THE 16F. HE WAS ABLE TO SUCCESSFULLY EXTRACT THE RA AND TARGETED RV LEAD WITH THE 16F LASER SHEATH. THE PATIENT TOLERATED THE PROCEDURE WELL AND NO INJURY OCCURRED. THIS EVENT IS BEING REPORTED BECAUSE OF THE RISK OF INJURY WITH RECURRENCE DUE TO THE LEAD GETTING STUCK INSIDE OF THE TIGHTRAIL, THEREFORE, REQUIRING CUTTING OF THE LEAD TO REMOVE THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    406141 SPECTRANETICS TIGHTRAIL ROTATING MECHANICAL DILATOR SHEATH 9F TIGHTRAIL DRE SPECTRANETICS CORPORATION 545-509 FRB14E14A

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Other ST. JUDE MEDICAL 1488T RA LEAD (IMPL 2 YEARS)| SPECTRANETICS 14F GLIDELIGHT LASER SHEATH| ST. JUDE MEDICAL 1488T RV LEAD (IMPL 12 YEARS)| 16F GLIDELIGHT LASER SHEATH| SPECTRANETICS LLD-E X2| SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM