BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECTRANETICS LASER SHEATH II

    MDR report key: 2537334 · Received April 16, 2012

    Report

    Report Number
    1721279-2012-00037
    Event Type
    Injury
    Date Received
    April 16, 2012
    Date of Event
    March 20, 2012
    Report Date
    March 21, 2012
    Manufacturer
    SPECTRANETICS CORPORATION
    Product Code
    MFA
    PMA / PMN Number
    P960042
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE DISPOSED OF AFTER USE.

    Description of Event or Problem · 1

    THIS (B)(6) FEMALE WHO UNDERWENT A CARDIAC LEAD EXTRACTION TO REMOVE A TOTAL OF 3 LEADS (GDT 4549 - LV, GDT 4244 - RA, GDT 0135 - RV) DUE TO ACUTE ENDOCARDITIS. THE CASE WAS CONDUCTED IN THE OR WITH ACTIVE FLUOROSCOPY, PATIENT INTUBATED AND PREPPED WITH AN ARTERIAL LINE, CVS AWARE OF CASE, AND CELL SAVER AVAILABLE IN THE ROOM. THE MD CUT AND PREPPED ALL LEADS WITH A LLD (LV - LLD-E, RA - LLD-EZ, RV - LLD-EZ). THE LV LEAD WAS LASED AND SUCCESSFULLY REMOVED WITH A 14F SLS II. THE RA LEAD WAS LASED AND SUCCESSFULLY REMOVED WITH A 16F SLS II. USING THE 16F SLS II THE MD BEGAN LASING THE RV LEAD. IT WAS APPARENT VIA FLUOROSCOPY THE LASER SHEATH WAS ADVANCED BEYOND THE VASCULAR WALL. THE PATIENT'S ABP DECLINED, THE CVS WAS PAGED AND CPR WAS INITIATED. THE MD REQUESTED THE PERICARDIOCENTESIS AND CHEST TRAY TO BE SET UP. APPROXIMATELY 8 MINUTES AFTER THE INITIAL ABP DECLINE THE MD PERFORMED THE PERICARDIOCENTESIS. APPROXIMATELY 10 MINUTES AFTER THE ABP DECLINE THE CVS ARRIVED AND PERFORMED A STERNOTOMY WITHIN 2 MINUTES. AN APICAL TEAR WAS FOUND AND REPAIRED. THE PATIENT RECEIVED A TOTAL OF 3 UNITS VIA THE CELL SAVER. THE PATIENT'S CHEST WAS CLOSED, THE PATIENT WAS STABILIZED AND TRANSFERRED TO THE ICU FOR RECOVERY. THERE WERE NO DEVICES RETAINED FOR RETURNED ANALYSIS. AN INTERNAL LHR REVIEW NOTED NO ISSUES OR NONCONFORMANCES. THE PHYSICIAN DID NOT INDICATE SPNC DEVICES TO BE RESPONSIBLE FOR THE PATIENT'S INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPECTRANETICS LASER SHEATH II 16F SLS II MFA SPECTRANETICS CORPORATION 500-013 CKK11L21B

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Life Threatening| R 14F SLS II| LLD-EZ| GDT (B)(4)| GDT (B)(4)| CVX-300 EXCIMER LASER| LLD-E| GDT (B)(4)