BEUDAMED
    FDA Adverse Event Death Summary report: N

    SPNC LASER SHEATH/LEAD LOCKING DEVICE

    MDR report key: 1561317 · Received December 15, 2009

    Report

    Report Number
    1721279-2009-00057
    Event Type
    Death
    Date Received
    December 15, 2009
    Date of Event
    December 3, 2009
    Report Date
    December 9, 2009
    Manufacturer
    SPECTRANETICS CORPORATION
    Product Code
    MFA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURER DATES FOR ALL DEVICES: 500-001 - 2009-JULY-01, 500-012 - 2009-FEBRUARY-18, 500-013 - 2009-JULY-20, 518-062 - 2009-OCTOBER-05.

    Description of Event or Problem · 1

    INDICATION FOR PROCEDURE: INFECTED, LEFT-SIDED IMPLANT. PROCEDURE: LEFT-SIDED PROCEDURE WAS CONDUCTED IN THE CARDIAC CATHETER LAB. BOTH FLUOROSCOPY AND AN ARTERIAL LINE WERE USED THROUGHOUT THE PROCEDURE. THE PROCEDURE UTILIZED A LLD-EZ, A 12F, A 14F AND 16F SLS. THE PHYSICIAN BEGAN LASING DOWN THE AV LEAD WITH A 12F, THEN UP SIZED TO A 14F SLS. MAKING VERY LITTLE PROGRESS THE PHYSICIAN DECIDED TO LASE THE RV LEAD AND UP SIZED TO A 16F SLS. PROXIMAL COIL WAS REACHED WHEN THE NURSE ALERTED THE PHYSICIAN TO THE PT'S FALLING BLOOD PRESSURE. SURGICAL TEAM RESPONDED WITHIN 15 SECONDS. ANALYSIS: THE DEVICES USED IN THIS CASE WERE NOT RETAINED BY THE HOSPITAL STAFF FOR POST-PROCEDURE ANALYSIS BY THE MANUFACTURER. LOT HISTORY REVIEWS FOUND NO ISSUES OR NON-CONFORMANCES RELATED TO THE REPORTED EVENT. PT'S OUTCOME: AFTER APPROXIMATELY 30 MINUTES OF CPR, THE PT EXPIRED. CAUSE OF DEATH IS UNK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPNC LASER SHEATH/LEAD LOCKING DEVICE 16F SLS/LLD-EZ MFA SPECTRANETICS CORPORATION 500-013/518-062 C09G20B/C09K05C

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention 12F SLS| GENERATION 4 EXCIMER LASER| 14F SLS