BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECTRANETICS LEAD LOCKING DEVICE

    MDR report key: 3822194 · Received May 20, 2014

    Report

    Report Number
    1721279-2014-00077
    Event Type
    Injury
    Date Received
    May 20, 2014
    Date of Event
    May 5, 2014
    Report Date
    May 5, 2014
    Manufacturer
    SPECTRANETICS CORPORATION
    Product Code
    DRB
    PMA / PMN Number
    K043401
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    DURING A LEAD EXTRACTION CASE, AN LLD WAS NOT ABLE TO BE INSERTED FULLY INTO THE TARGETED LEAD. A TIGHTRAIL WAS USED TO SUCCESSFULLY RELIEVE BINDING SITES IN THE SUBCLAVIAN, INNOMINATE, SVC, SVC/RA JUNCTION. ADDITIONAL TRACTION FORCE WAS APPLIED TO THE LEAD USING THE LLD, AND THE LEAD BEGAN TO UNRAVEL AND SEPARATE 5CM DISTAL TO THE MOST DISTAL POINT WHERE THE TIGHTRAIL WAS USED. THE LEAD SEPARATION OCCURRED DISTAL TO THE FURTHEST POINT THAT THE LLD COULD BE INSERTED. PRIOR DAMAGE TO THE LEAD WAS NOT ABLE TO BE SEEN ON FLUORO PRIOR TO THE PROCEDURE, HOWEVER, IT IS BELIEVED THAT THERE WAS SOME PRE-EXISTING COMPROMISE TO THE LEAD'S INTEGRITY THAT PREVENTED THE LLD FROM BEING INSERTED ALL THE WAY TO THE END OF THE LEAD. THE PHYSICIAN BELIEVED THAT IT WAS THE COMPROMISE IN THE LEAD THAT CAUSED IT TO SEPARATE AND NOT THE LLD. BECAUSE OF THE POTENTIAL FOR INJURY WITH RECURRENCE AND BECAUSE THE LLD WAS USED AS A TRACTION PLATFORM WHEN THE LEAD CAME APART, WE ARE REPORTING THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    299935 SPECTRANETICS LEAD LOCKING DEVICE LLD-EZ DRB SPECTRANETICS CORPORATION 518-062 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Other SPECTRANETICS TIGHTRAIL ROTATING DILATOR SHEATH| BOSTON SCIENTIFIC ACUITY SPIRAL 4591 (IMPL 69 MON)