BEUDAMED
    FDA Adverse Event Death Summary report: N

    SPECTRANETICS GLIDELIGHT LASER SHEATH

    MDR report key: 4182979 · Received October 17, 2014

    Report

    Report Number
    1721279-2014-00174
    Event Type
    Death
    Date Received
    October 17, 2014
    Date of Event
    October 4, 2014
    Report Date
    October 8, 2014
    Manufacturer
    SPECTRANETICS CORPORATION
    Product Code
    MFA
    PMA / PMN Number
    P960042
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    NEW INFORMATION RECEIVED REGARDING THIS EVENT AND UPDATED IN THIS REPORT INCLUDE: DATE OF EVENT PATIENT DEMOGRAPHICS INCLUDING AGE, SEX, WEIGHT RELEVANT TESTS / LABORATORY DATA OTHER RELEVANT HISTORY / CO-MORBIDITIES DESCRIPTION OF EVENT CARDIAC LEAD INFORMATION CONCOMITANT MEDICAL PRODUCTS.

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT IS BEING FILED AS NO INFORMATION COULD BE OBTAINED TO DETERMINE IF SPECTRANETICS DEVICES WERE INVOLVED OR CONTRIBUTED TO THE DEATH OF THIS PATIENT. IF APPLICABLE ADDITIONAL INFORMATION IS OBTAINED, A FOLLOW-UP WILL BE SUBMITTED.

    Description of Event or Problem · 1

    CONVERSATION OVERHEAD AT THE FACILITY IDENTIFIED THAT A PATIENT DIED AFTER A TREATMENT WITH THE EXCIMER LASER. A SECOND INDIVIDUAL ADDED THAT THE DEATH OCCURRED AFTER A LEAD EXTRACTION. THE PHYSICIAN WAS LASING INTO THE HARD TISSUE AND DAMAGED IT, RESULTING IN THE PATIENT DEATH. ALL ATTEMPTS TO OBTAIN INFORMATION HAVE BEEN UNSUCCESSFUL.

    Description of Event or Problem · 1

    UPDATED DETAILS RECEIVED FROM FACILITY REGARDING EVENT: THIS WAS A LEFT-SIDED LEAD EXTRACTION CASE TO REMOVE ONE RV LEAD (SJM DUAL COIL RIATA ST OPTIM, IMPLANTED 84 MONTHS) DUE TO CIED SYSTEM INFECTION. THE LEAD WAS PREPPED WITH AN #2 LLD AND A GLIDELIGHT LASER SHEATH WAS USED TO EXTRACT. STEADY PROGRESS WAS MADE WITH THE GLIDELIGHT AND THE LEAD WAS EXTRACTED SUCCESSFULLY. AFTER REMOVAL OF THE LEAD, THE PATIENT'S BLOOD PRESSURE DECLINED AND RESCUE MEASURES WERE INITIATED, INCLUDING A STERNOTOMY. A 3CM TEAR IN THE SVC WAS FOUND. ATTEMPTS TO REPAIR THE INJURY AND SAVE THE PATIENT WERE UNSUCCESSFUL AND THE PATIENT DID NOT SURVIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    661841 SPECTRANETICS GLIDELIGHT LASER SHEATH GLIDELIGHT MFA SPECTRANETICS CORPORATION UNKNOWN UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Death SJM RIATA ST OPTIM RV ICD LEAD (IMPL 84 MON)| SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM| SPECTRANETICS LEAD LOCKING DEVICE (LLD #2)| CVX-300 EXCIMER LASER