BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECTRANETICS LASER SHEATH II

    MDR report key: 2400649 · Received January 3, 2012

    Report

    Report Number
    1721279-2011-00107
    Event Type
    Injury
    Date Received
    January 3, 2012
    Date of Event
    December 8, 2011
    Report Date
    December 8, 2011
    Manufacturer
    SPECTRANETICS CORP.
    Product Code
    MFA
    PMA / PMN Number
    P960042
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE ANALYSIS RESULTS: A 14F SLS II WAS RECEIVED ON (B)(4) 2012 AND ANALYZED ON (B)(4) 2012. THE PRODUCT WAS RECEIVED FOLDED AND SEALED IN A SMALL BAG CREATING SEVERAL KINKS IN THE DEVICE. THERE WERE NO BREAKS IN THE OUTER JACKET OF THE SHEATH. IT IS UNKNOWN TO THE MANUFACTURER WHETHER THE KINKS WERE A RESULT OF THE PACKAGING/RETURN OF THE DEVICE OR IF THEY OCCURRED DURING USE. VISUAL INSPECTION NOTED NO LOOSE CONNECTIONS, BROKEN COMPONENTS, DISTAL TIP DAMAGE, OR FIBER OPTIC COUPLER DAMAGE. THE LIGHT SOURCE EVALUATION REVEALED 2 DEAD FIBERS AT THE TIP. ASIDE FROM THE KINKS, NO OTHER DEVICE DAMAGE WAS NOTED. THERE ARE NO ISSUES WITH THE DEVICE RELATED TO THE ADVERSE EVENT AND WITHOUT BEING ABLE TO DETERMINE THE SOURCE OF THE KINKS, THE ROOT CAUSE IS "USE ERROR CAUSED OR CONTRIBUTED TO EVENT".

    Description of Event or Problem · 1

    THIS WAS A LEFT-SIDED, CARDIAC LEAD REMOVAL CASE PERFORMED IN THE EP LAB TO REMOVE A TOTAL OF THREE LEADS (MDT 4557M-RAM (B)(6); MDT 4076-RV, (B)(6); MDT 4068-CAPPED RV LEAD, (B)(6)) DUE TO A SVC OCCLUSION AND REMOVAL OF A NONFUNCTIONAL LEAD. THE PATIENT WAS PREPPED WITH AN ARTERIAL LINE, CT SURGEON WAS PRESENT AND BOTH FLUOROSCOPY AND TEE WERE IN ACTIVE USE DURING THE PROCEDURE. BASELINE ARTERIAL BLOOD PRESSURE WAS 104/57. THE MD PREPPED THE 4076 RV LEAD WITH A LLD-EZ AND BEGAN LASING WITH THE 14F SLS II AND 14F VISISHEATH 33CM, ADVANCING INTO THE SVC WERE ALL THREE LEADS WERE ADHERED TOGETHER AND ADVANCEMENT STOPPED. A 16F SLS II WAS OPENED, THE 4557M RA LEAD WAS PREPPED WITH A LLD-EZ AND LASING BEGAN. WHILE LASING THE RA LEAD THE 4076 RV LEAD DETACHED FROM THE LEAD TIP. THE 16F SLS II WAS REMOVED FROM THE RA LEAD, SWITCHING BACK TO THE 14F SLS II EXTRACTING THE REMAINDER OF THE 4076 RV LEAD. THE MD THEN ATTEMPTED TO INSERT TWO GUIDE WIRES FOR LEAD RE-IMPLANTATION, BUT WAS UNSUCCESSFUL. AT THIS POINT THE PATIENT'S BLOOD PRESSURE HAD SLOWLY DECLINED FROM 76/47, 65/41, 60/39, AND ULTIMATELY TO 58/39. DOPAMINE GIVEN, BLOOD PRESSURE INCREASED, 4557M RA LEAD WAS CUT/CAPPED AND 4068 RV REMAINED CAPPED. WHILE THE PATIENT REMAINED STABLE, A NEW SYSTEM WAS IMPLANTED ON THE RIGHT SIDE. NEAR THE END OF THE IMPLANT THE PATIENT'S PRESSURE DROPPED AGAIN AND A POSSIBLE SVC INJURY WAS NOTED ON FLUOROSCOPY. THE OPERATING ROOM WAS NOTIFIED, THE PATIENT WAS TRANSFERRED AND AN EMERGENT STERNOTOMY PERFORMED WITHIN SEVEN MINUTES. A POSTERIOR, INNOMINATE/SVC JUNCTION TEAR WAS FOUND AND SUCCESSFULLY REPAIRED. THE PATIENT WAS TRANSFERRED TO THE ICU AND ULTIMATELY MADE A FULL RECOVERY AND DISCHARGED HOME. AN INTERNAL LHR REVIEW NOTED NO ISSUES OR NONCONFORMANCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPECTRANETICS LASER SHEATH II 14F SLS II MFA SPECTRANETICS CORP. 500-012 CJJ11K17F

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Hospitalization| L| R MDT 4557 (RA)| LLD-EZ (518-062)| CVX-300 EXCIMER LASER: (SERIAL # (B)(4))| SCREW:| MDT 4068 (RV) CAPSURE FIX IS-1 BIPOLAR RETRACTABLE| MDT 4076 (RV) CAPSUREFIX NOVUS BIPOLAR RETRACTABLE| 14F VISISHEATH 33CM (501-114)| 16F SLS II (500-013)| SCREW: