BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECTRANETICS LASER SHEATH II

    MDR report key: 2013385 · Received March 8, 2011

    Report

    Report Number
    1721279-2011-00011
    Event Type
    Injury
    Date Received
    March 8, 2011
    Date of Event
    February 16, 2011
    Report Date
    February 16, 2011
    Manufacturer
    SPECTRANETICS CORPORATION
    Product Code
    MFA
    PMA / PMN Number
    P960042
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THIS PATIENT WAS REFERRED TO THIS FACILITY AFTER A FAILED LEAD EXTRACTION. TWO LEADS WERE CUT AND RETRACTED INTO THE HEART. THIS CASE WAS PERFORMED IN THE HYBRID OPERATING ROOM SUITE WITH ARTERIAL LINE PLACEMENT AND FLUOROSCOPY. A STERNOTOMY WAS DISCUSSED PRE-OPERATIVELY IF THE MEDICAL DOCTOR WAS UNABLE TO GAIN CONTROL OF THE 2 CARDIAC LEADS (BOTH RV). THE MEDICAL DOCTOR WAS ABLE TO SECURE THE FIRST LEAD WITH A LLD-EZ AND BEGAN LASING WITH A 14F SLS, THEN UPSIZED TO THE 16F SLS. AS THE MEDICAL DOCTOR WAS IN THE RA/SVC JUNCTION WITH THE 16F SLS, THE RV LEAD BECAME FREE AND WAS EXTRACTED. THE PATIENT'S ARTERIAL BLOOD PRESSURE STARTED TO DROP AND THE MEDICAL DOCTOR PERFORMED AN EMERGENT STERNOTOMY. THE MEDICAL DOCTOR DISCOVERED THAT THE PERFORATION WAS IN THE APEX OF THE RV. HE SUCCESSFULLY REPAIRED THE RV PERFORATION WITH A PURSE STRING SUTURE, THEN MADE AN INCISION INTO THE RA AND GRABBED THE REMAINING LEAD AND MANUALLY EXTRACTED IT. THE PATIENT RECOVERED WITHOUT FURTHER REPORTED COMPLICATIONS. ALL SPNC DEVICES USED DURING THE CASE WERE DISPOSED OF DURING THE CODE. SEVERAL ATTEMPTS (02/16, 02/18, 02/20) WERE MADE TO OBTAIN LOT HISTORY INFORMATION WITHOUT SUCCESS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Life Threatening| R EXCIMER LASER SYSTEM: CVX-300, SERIAL# (B)(4)| LLD-EZ: 518-062, LOT# UNKNOWN| 14F SLS II: 500-012, LOT# UNKNOWN