BEUDAMED
    FDA Adverse Event Other Summary report: N

    LEAD LOCKING DEVICE EZ/ SPNC LASER SHEATH II

    MDR report key: 1198946 · Received September 26, 2008

    Report

    Report Number
    1721279-2008-00024
    Event Type
    Other
    Date Received
    September 26, 2008
    Date of Event
    August 27, 2008
    Report Date
    September 23, 2008
    Manufacturer
    SPECTRANETICS CORP.
    Product Code
    MFA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT OUTCOME: PROCEEDING THE INITIAL PROCEDURE AND INTERVENTION, THE PT WAS TRANSFERRED TO THE ICU IN STABLE CONDITION. UNFORTUNATELY THE PATIENT WENT INTO RENAL FAILURE AND DIED APPROXIMATELY 4 DAYS LATER. FAILURE ANALYSIS: THE FAILURE ANALYSIS WAS UNABLE TO BE PERFORMED BECAUSE NO DEVICES FROM THIS CASE WERE RETURNED TO THE MANUFACTURER. HOWEVER, THERE IS NO INDICATION THAT THE EVENT WAS CAUSED BY A MALFUNCTION OF THE SPECTRANETICS DEVICES.

    Description of Event or Problem · 1

    CLINICAL HISTORY: PT WAS AN (B) (6) MALE ADMITTED FOR AN EMERGENT LEAD REMOVAL SECONDARY TO AN ACUTE POCKET INFUSION. PROCEDURE: TWO 14.5 YEAR OLD, UNIPOLAR BRADY LEADS WERE TO BE REMOVED BY (B) (6). BOTH LEADS CAME APART AS TRACTION WAS APPLIED SEPARATELY WITH LLD-EZS, INCREASING THE COMPLEXITY OF THE PROCEDURE. MD BEGAN WITH A 12F SLS AND UPGRADED TO A 14F SLS ONCE THE INITIAL SLS FAILED CALIBRATION AFTER MANIPULATION. THE 14F SLS WAS USED TO COMPLETE THE CASE AND WAS RESPONSIBLE FOR THE REMOVAL OF BOTH LEADS. THE VENTRICULAR LEAD WAS REMOVED FIRST. WHEN ATTEMPTING TO REMOVE THE ATRIAL LEAD, THE LEAD BECAME LOOSE ABRUPTLY AND SEEMED THE REMAINING FORCE ON THE SLS LACERATED THE SVC AND ATRIUM LEADING TO A SINGLE PERFORATION AT THIS JUNCTION SITE. MD NOTED THE LACK OF WALL MOTION IN THE LEFT VENTRICLE UNDER FLUORO AND CONFIRMED THE BLEEDING WITH ANAESTHESIOLOGIST (A-LINE & TEE). A THORACOTOMY WAS PERFORMED, SVC REPAIRED SUCCESSFULLY AND PT TRANSFERRED TO THE ICU.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LEAD LOCKING DEVICE EZ/ SPNC LASER SHEATH II LLD EZ / 14F SLS II MFA SPECTRANETICS CORP. 518-062/500-012 UNK/UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Death| R SPECTRANETICS CVX-300 LASER