BEUDAMED
    FDA Adverse Event Death Summary report: N

    SPNC LASER SHEATH

    MDR report key: 1526726 · Received November 12, 2009

    Report

    Report Number
    1721279-2009-00050
    Event Type
    Death
    Date Received
    November 12, 2009
    Date of Event
    September 23, 2009
    Report Date
    November 11, 2009
    Manufacturer
    SPECTRANETICS CORP.
    Product Code
    MFA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    INDICATION FOR PROCEDURE: LEAD MALFUNCTIONING. PROCEDURE: THIS WAS A RIGHT-SIDED PROCEDURE PERFORMED IN THE CATH LAB, WITH AN ARTERIAL LINE AND FLUOROSCOPY MONITORING. THE PHYSICIAN INSERTED A LLD#2 INTO THE LEAD AND LASED WITH A 16F SLS FOR APPROXIMATELY 3 MINUTES WHEN IT WAS NOTED THE PT'S BLOOD PRESSURE WAS DROPPING. A TRANS ESOPHAGEAL ECHOCARDIOGRAM REVEALED A POSSIBLE SVC RUPTURE AND PERICARDIAL EFFUSION. THE CT SURGEON INSERTED A PARACENTESIS CATHETER WITH LITTLE IMPROVEMENT. THE PT UNDERWENT EMERGENT OPEN-HEART SURGERY, BUT UNFORTUNATELY, DID NOT SURVIVE THE PROCEDURE. DEVICE ANALYSIS: THE DEVICE WAS NOT RETURNED TO THE MANUFACTURE. PER LOT HISTORY REVIEW THERE WERE NO ISSUES OR NONCONFORMANCES RELATED TO THE REPORTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPNC LASER SHEATH 16F SLS MFA SPECTRANETICS CORP. 500-013 C09F23A

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Death GENERATION 4 EXCIMER LASER| LEAD LOCKING DEVICE #2 (LLD)