BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECTRANETICS LASER SHEATH

    MDR report key: 1627993 · Received March 9, 2010

    Report

    Report Number
    1721279-2010-00004
    Event Type
    Injury
    Date Received
    March 9, 2010
    Date of Event
    February 2, 2010
    Report Date
    February 15, 2010
    Manufacturer
    SPECTRANETICS CORP.
    Product Code
    MFA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURER DATES FOR ALL DEVICES: (B) (4) UNKNOWN.

    Description of Event or Problem · 1

    INDICATION FOR PROCEDURE: ACUTE INFECTION. PROCEDURE: THIS WAS A LEFT SIDED, DUAL CHAMBER PACING SYSTEM LEAD REMOVAL PERFORMED IN THE EP LAB. APPROXIMATE 5-6 YEAR OLD LEADS (1 ACTIVE, 1 PASSIVE) TO BE REMOVED. MD BEGAN WITH COOK DILATOR SHEATH TO REMOVE THE VENTRICULAR LEAD. UPON REMOVAL OF THE LEAD, THE MD NOTED TISSUE ON THE DISTAL END OF THE LEAD. THE PATIENT'S BLOOD PRESSURE BEGAN SLOWLY DROPPING AND THE CT SURGEON WAS PAGED. THE 12F SLS HAD BEEN PREPPED, MD LASED OVER ATRIAL LEAD SUCCESSFULLY REMOVING IT. A PERICARDIOCENTESIS WAS PERFORMED, CT SURGEON ARRIVED AND BEGAN WITH A XIPHOID WINDOW TO REPAIR THE RV PERFORATION. ULTIMATELY A FULL STERNOTOMY WAS PERFORMED TO REPAIR THE INJURY. ANALYSIS: THERE WERE NO DEVICES RETURNED FROM THIS CASE. MD INDICATED NO MALFUNCTIONS OF DEVICES USED. PATIENT OUTCOME: PATIENT RECOVERED AND WAS DISCHARGED WITH NO REPORTED DEFICITS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPECTRANETICS LASER SHEATH 12F SLS MFA SPECTRANETICS CORP. 500-001 C09H10B

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention COOK GREEN BYRD DILATOR SHEATH| GENERATION 4 EXCIMER LASER