BEUDAMED
    FDA Adverse Event Death Summary report: N

    SPECTRANETICS LASER SHEATH II

    MDR report key: 2902391 · Received January 8, 2013

    Report

    Report Number
    1721279-2012-00189
    Event Type
    Death
    Date Received
    January 8, 2013
    Date of Event
    December 18, 2012
    Report Date
    December 18, 2012
    Manufacturer
    SPECTRANETICS CORPORATION
    Product Code
    MFA
    PMA / PMN Number
    P960042
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THIS WAS A LEFT-SIDED LEAD EXTRACTION PERFORMED IN THE EP LAB TO REMOVE A MALFUNCTIONING RV, SJM 1581 RIATA LEAD (122 MONTHS OLD). THE PATIENT HAD A TOTAL OF 2 LEADS, RV AND AN UNKNOWN RA LEAD. PRE-OPERATIVE FLUOROSCOPY SHOWED THE RV DISTAL TIP TO BE PERFORATED. THE PATIENT WAS PREPPED PER HRS STANDARD RECOMMENDATIONS WITH CVS AVAILABLE. THE RA LEAD WAS PREPPED WITH A COOK LIBERATOR. THE MD PLACED TRACTION ON THE RA LEAD WITH THE LIBERATOR AND A CARDIAC TAMPONADE WAS NOTED ON FLUOROSCOPY. THE CVS WAS REQUESTED TO COME INTO THE LAB. WITHIN A MINUTE A PERICARDIOCENTESIS WAS BEING PERFORMED AND A UNIT OF BLOOD WAS HUNG. A SECOND CVS ENTERED THE ROOM AND THE PATIENT WAS INTUBATED. APPROXIMATELY 25 MINUTES LATER A SECOND UNIT OF BLOOD WAS HUNG AND A NEW PROCEDURE TRAY WAS OPENED. AT 19 MINUTES LATER A COOK LIBERATOR WAS INSERTED INTO THE RV LEAD. LASING ON THE RA LEAD WITH A 14F SLS II BEGAN 12 MINUTES LATER SUCCESSFULLY EXTRACTING THE LEAD. AT 17 MINUTES LATER THE 14F SLS II WAS ADVANCED OVER THE RV LEAD. AT 15 MINUTES LATER THE 14F SLS II WAS REMOVED AND REPLACED WITH A 16F SLS II WITH THE ADDITION OF A L-VISISHEATH 33CM. WITHIN 4 MINUTES THE PATIENT'S ABP DROPPED AND WITHIN 7 MINUTES OF BEING PAGED THE CVSS RETURNED. A SECOND PERICARDIOCENTESIS WAS PERFORMED 7 MINUTES LATER AND WITHIN 19 MINUTES A STERNOTOMY WAS BEING PERFORMED. UPON OPENING THE PATIENT'S CHEST AN INJURY AT THE SVC/RA JUNCTION WAS NOTED. UNFORTUNATELY RESUSCITATIVE EFFORTS WERE NOT SUCCESSFUL AND THE PATIENT DIED ON THE TABLE. THE MD STATED THE PATIENT'S INJURY WAS CAUSED BY THE SPNC DEVICES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    9113 SPECTRANETICS LASER SHEATH II 16 SLS II MFA SPECTRANETICS CORPORATION 500-013 CKK11L23D

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Death RA LEAD (UNKNOWN MODEL#)| CVX-300 EXCIMER LASER SYSTEM| L - VISISHEATH 33CM| 14F SLS II| COOK LIBERATOR| SJM 1581 RIATA DUAL COIL