BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPECTRANETICS LEAD LOCKING DEVICE

    MDR report key: 3873527 · Received June 14, 2014

    Report

    Report Number
    1721279-2014-00096
    Event Type
    Malfunction
    Date Received
    June 14, 2014
    Date of Event
    June 4, 2014
    Report Date
    June 4, 2014
    Manufacturer
    SPECTRANETICS CORPORTATION
    Product Code
    DRB
    PMA / PMN Number
    K043401
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    REPORT FOR THE GLIDELIGHT IS MDR REPORT 1721279-2014-00095.

    Description of Event or Problem · 1

    LEAD MANAGEMENT CASE TO EXTRACT TWO CARDIAC LEADS DURING A GEN CHANGE. THE FIRST LEAD WAS A 1581 RIATA (IMPL. (B)(6) 2006 IN THE RV), DUE TO EXPOSED CABLES THE DECISION WAS MADE TO USE A 16F GLIDELIGHT FOR EXTRACTION. AN LLD EZ WAS USED TO PREP THE LEAD AND LASING BEGAN WITH THE GLIDELIGHT. THE GLIDELIGHT WAS MOVING SLOWLY AND SMOOTHLY WITH NO INDICATION OF A COMPLICATION, UPON ENTERING THE RA PROGRESS WAS HALTED AND IT WAS NOTICED UNDER FLUOROSCOPY THAT THE LEAD STARTED TO BUNCH UP. A LITTLE MORE PROGRESS WAS ATTEMPTED BEFORE DECIDING TO CHANGE OVER TO THE RA LEAD (SJM VENTRATEK MODEL NUMBER UNKNOWN IMPLANTED (B)(6) 2006) WHEN THE BLOOD PRESSURE DROPPED. THE SURGEON IMMEDIATELY PERFORMED A STERNOTOMY AND ON EXAMINATION OF THE SITE IT WAS DISCOVERED THAT THE ENTIRE INNOMINATE WAS TORN. IT WAS BELIEVED BY THE PHYSICIAN THAT THE LEAD HAD BEEN EXTRA-CARDIAC PROVIDING AN EXTERNALIZED TRACK FOR THE GLIDELIGHT TO FOLLOW CAUSING THE TEAR. THE INNOMINATE INJURY WAS REPAIRED AND EXTRACTION ATTEMPTS WERE STOPPED FOR FEAR OF CAUSING THE VESSEL TO TEAR FURTHER. THE LLD EZ WAS CUT AND CAPPED WITHIN THE LEAD. THE PATIENT SURVIVED INTERVENTION. THIS REPORT IS TO REFLECT THE ABANDONMENT OF THE LLD EZ.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    351852 SPECTRANETICS LEAD LOCKING DEVICE LLD EZ DRB SPECTRANETICS CORPORTATION 518-062 FLP14A14A

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Other SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM| SPECTRANETICS 16F GLIDELIGHT LASER SHEATH| SJM 1581 RIATA CARDIAC LEAD (IMPL. (B)(6) 2006)| SJM VENTRATEK (UNK MODEL # IMPL. (B)(6) 2006)