BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECTRANETICS TIGHTRAIL ROTATING DILATOR SHEATH

    MDR report key: 4241562 · Received November 10, 2014

    Report

    Report Number
    1721279-2014-00185
    Event Type
    Injury
    Date Received
    November 10, 2014
    Date of Event
    October 20, 2014
    Report Date
    October 20, 2014
    Manufacturer
    SPECTRANETICS CORPORATION
    Product Code
    DRE
    PMA / PMN Number
    K140047
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    UDI: (B)(4).

    Description of Event or Problem · 1

    THIS WAS A BILATERAL LEAD EXTRACTION PROCEDURE TO REMOVE TWO RV LEADS DUE TO CIED SYSTEM INFECTION. THE FIRST RV LEAD (IMPLANTED LESS THAN 1 YEAR) WAS REMOVED VIA A RIGHT-SIDED APPROACH USING A STANDARD STYLET AND MANUAL TRACTION ONLY. A 13F TIGHTRAIL WAS USED ON THE SECOND RV LEAD (IMPLANTED 84 MONTHS) USING A LEFT-SIDED APPROACH, HOWEVER, THE LEAD BEGAN TO DISINTEGRATE AND FELL APART. THE PHYSICIAN ATTEMPTED TO SNARE THE REMAINING LEAD VIA A FEMORAL SNARE APPROACH USING A NEEDLE SNARE FOLLOWED BY A GOOSENECK SNARE. ALTHOUGH SUCCESSFULLY SNARING THE LEAD, IT WOULD NOT COME DOWN THROUGH THE IVC. AT THIS POINT, IT WAS DECIDED TO PERFORM A SURGICAL INTERVENTION IN ORDER TO COMPLETELY REMOVE THE LEAD AS IT WAS INFECTED AND REQUIRED TOTAL EXTRACTION. THE PATIENT WAS TAKEN TO THE OPERATING ROOM AND A THORACOTOMY WAS PERFORMED IN ORDER TO REMOVE THE LEAD. IT WAS NOTED BY THE PHYSICIAN THAT THERE WAS CONTINUED DIFFICULTY REMOVING THE LEAD MANUALLY DURING THE THROACOTOMY. THE LEAD WAS PART OF THE POSTERIOR WALL OF THE RIGHT ATRIUM AND THE TRICUSPID VALVE AND THERE WAS A SIGNIFICANT AMOUNT OF RIGHT VENTRICLE ADHERED TO THE TIP. IT WAS ALSO STATED BY THE PHYSICIAN THAT EXTRACTING THE LEAD SURGICALLY WAS THE BEST COURSE FOR THIS LEAD AS ANY OTHER METHOD WOULD HAVE RESULTED IN INJURY AND POSSIBLY DEATH. THIS EVENT IS BEING REPORTED BECAUSE THE TIGH-TRAIL, ALTHOUGH IT PERFORMED APPROPRIATELY, CONTRIBUTED TO THE DISINTEGRATION OF THE LEAD WHICH REQUIRED MEDICAL INTERVENTION TO BE EXTRACTED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    722524 SPECTRANETICS TIGHTRAIL ROTATING DILATOR SHEATH 13F TIGHTRAIL DRE SPECTRANETICS CORPORATION 545-513 FRD14F19A

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| O| R RV LEAD (INFORMATION UNKNOWN)| RV ICD LEAD (INFORMATION UNKNOWN)