BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECTRANETICS LEAD LOCKING DEVICE

    MDR report key: 4182874 · Received October 17, 2014

    Report

    Report Number
    1721279-2014-00177
    Event Type
    Injury
    Date Received
    October 17, 2014
    Date of Event
    October 6, 2014
    Report Date
    October 6, 2014
    Manufacturer
    SPECTRANETICS CORPORATION
    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

    ADDED WEIGHT, RELEVANT TESTS, RELEVANT HISTORY CORRECTED CONCOMITANT FROM SPECTRANETICS LLD TO SPECTRANETICS LLD-EZ.

    Description of Event or Problem · 1

    THIS WAS A LEAD EXTRACTION CASE PERFORMED IN THE CATH LAB TO REMOVE 4 LEADS DUE TO CIED SYSTEM INFECTION. THE PHYSICIAN WAS ATTEMPTING TO REMOVE A PREVIOUSLY ABANDONED RA LEAD (SJM 1342T, IMPLANTED IN 1998 AND CAPPED/ABANDONED IN 2004). THE PHYSICIAN ENCOUNTERED CALCIFICATION IN THE SVC INNOMINATE/SVC AREA. HE STOPPED LASING AND BEGAN TO MANUALLY DISSECT THE BINDING SIGHT WITH THE USE OF THE LASER CATHETER AND OUTER SHEATH. THE BLOOD PRESSURE DROPPED AND THE ANESTHESIOLOGIST NOTICED EXCESS FLUID IN THE PERICARDIUM VIA TEE. THE CT SURGEON WAS CALLED INTO THE ROOM AND A PERICARDIAL WINDOW AND PERICARDIOCENTESIS TO DRAIN THE PERICARDIAL SACK WAS PERFORMED. A CHEST TUBE WAS PUT INTO THE PATIENT AND THE PROCEDURE WAS ABORTED. THIS REPORT IS BEING FILED AS AN LLD WAS LEFT INSIDE THE RA LEAD WHEN IT WAS CUT AND CAPPED.

    Description of Event or Problem · 1

    THIS WAS A LEAD EXTRACTION CASE PERFORMED IN THE CATH LAB TO REMOVE 4 LEADS DUE TO CIED SYSTEM INFECTION. THE PHYSICIAN WAS ATTEMPTING TO REMOVE A PREVIOUSLY ABANDONED RA LEAD (SJM 1342T, IMPLANTED IN 1998 AND CAPPED/ABANDONED IN 2004). THE PHYSICIAN ENCOUNTERED CALCIFICATION IN THE SVC INNOMINATE/SVC AREA. HE STOPPED LASING AND BEGAN TO MANUALLY DISSECT THE BINDING SIGHT WITH THE USE OF THE LASER CATHETER AND OUTER SHEATH. THE BLOOD PRESSURE DROPPED AND THE ANESTHESIOLOGIST NOTICED EXCESS FLUID IN THE PERICARDIUM VIA TEE. THE CT SURGEON WAS CALLED INTO THE ROOM AND A PERICARDIAL WINDOW AND PERICARDIOCENTESIS TO DRAIN THE PERICARDIAL SACK WAS PERFORMED. A CHEST TUBE WAS PUT INTO THE PATIENT AND THE PROCEDURE WAS ABORTED. THIS REPORT IS BEING FILED AS AN LLD WAS LEFT INSIDE A LEAD WHEN IT WAS CUT AND CAPPED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    661338 SPECTRANETICS LEAD LOCKING DEVICE LLD-EZ DRB SPECTRANETICS CORPORATION 518-062 FLP14E05A

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Other SJM 1688T CARDIAC LEAD (X2)| SPECTRANETICS GLIDELIGHT LASER SHEATH| SJM 1346T CARDIAC LEAD| SPECTRANETICS LLD| SJM 1342T CARDIAC LEAD| CVX-300 EXCIMER LASER