BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPNC LASER SHEATH/LEAD LOCKING DEVICE

    MDR report key: 1696236 · Received May 20, 2010

    Report

    Report Number
    1721279-2010-00023
    Event Type
    Injury
    Date Received
    May 20, 2010
    Date of Event
    May 5, 2010
    Report Date
    May 20, 2010
    Manufacturer
    SPECTRANETICS CORP.
    Product Code
    MFA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURE DATES FOR ALL DEVICES: UNK. ANALYSIS: THERE WERE NO DEVICES RETURNED FOR ANALYSIS. NO PRODUCT-RELATED COMPLAINTS ASSOCIATED WITH THIS EVENT WERE REPORTED BY THE PHYSICIAN. PATIENT OUTCOME: PT WAS STABLE AND RECOVERING IN ICU.

    Description of Event or Problem · 1

    INDICATION FOR PROCEDURE: BI-V UPGRADE WITH 6 ADDITIONAL ABANDONED LEADS (3 RIGHT, 2 LEFT & 1 EPICARDIAL). PROCEDURE: THE WAS A BILATERAL, LEAD REMOVAL PROCEDURE CONDUCTED IN THE OPERATING ROOM. MD BEGAN BY PREPPING THE LEAD'S DISTAL TIPS WITH A LLD-EZ, THEN LASING WITH A 14F SLS TO SUCCESSFULLY REMOVE THE 2 LEFT LEADS. MD THEN MOVED TO THE RIGHT SIDE ATTACHING ANOTHER LLD-EZ TO THE LEAD'S DISTAL TIP, THEN LASING WITH THE 14F SLS. AFTER LASING FOR APPROXIMATELY 1.5 MINUTES, THE MD UP SIZING TO A 16F SLS. CONTINUED TO LASE FOR APPROXIMATELY 2 MINUTES, THEN REQUESTED ANOTHER 16F SLS. MD CONTINUES TO LASE FOR ANOTHER 3 MINUTES, THE PT'S BLOOD PRESSURE DROPPED, CT SURGEON CALLED INTO THE ROOM, ORDERED BLOOD PRODUCTS TO BE HUNG IMMEDIATELY. THE MD PROCEEDED TO CONTINUE MANUALLY FOR APPROXIMATELY 2 MINUTES THEN CALLED A CODE BLUE. CPR WAS STARTED, THE OPEN HEART TEAM ENTERED THE ROOM, A SVC TEAR WAS FOUND AND REPAIRED VIA A PERICARDIAL WINDOW WITHIN 10 MINUTES. THE REMAINING LEADS WERE CAPPED, PT WAS CLOSED AND TRANSFERRED TO THE ICU TO RECOVER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPNC LASER SHEATH/LEAD LOCKING DEVICE 16F SLS / LLD-EZ MFA SPECTRANETICS CORP. 500-013 / 518-062 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention VISISHEATH (43 CM L)| GENERATION 4 EXCIMER LASER| 14F SLS (500-012/UNK SERIAL #)