BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECTRANETICS GLIDELIGHT LASER SHEATH

    MDR report key: 4243619 · Received November 11, 2014

    Report

    Report Number
    1721279-2014-00188
    Event Type
    Injury
    Date Received
    November 11, 2014
    Date of Event
    October 20, 2014
    Report Date
    October 20, 2014
    Manufacturer
    SPECTRANETICS CORPORATION
    Product Code
    MFA
    PMA / PMN Number
    P960042
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    BECAUSE OF THE INJURY THAT OCCURRED, THE PHYSICIAN ELECTED TO CUT AND CAP THE LEAD WITH THE LLD INSIDE. THIS WILL BE CAPTURED IN MDR REPORT # 1721279-2014-00197.

    Description of Event or Problem · 1

    THIS WAS A LEFT-SIDED LEAD EXTRACTION PROCEDURE TO REMOVE ONE 132 MONTH OLD MALFUNCTIONING MDT 6947 RV ICD LEAD. THE PLAN WAS TO EXTRACT THE MALFUNCTIONING 6947 AND PLACE A NEW SINGLE COIL ICD LEAD AND AN INTRACARDIAC LV LEAD. THE 6947 RV LEAD WAS PREPPED WITH AN LLD AND A 16F GLIDELIGHT WAS USED FOR THE EXTRACTION. AFTER ADVANCING THE LASER SHEATH PAST THE ICD LEAD'S PROXIMAL COIL AND APPROACHING THE IVC, IT WAS NOTED THAT THE "HEEL" OF THE LEAD WAS STILL APPROXIMATE TO THE IVC BY FLUOROSCOPY. THE LASER SHEATH WAS ADVANCED TO THIS SEGMENT AND THEN A CONSISTENT DROP IN THE PATIENT'S BLOOD PRESSURE WAS NOTED. AFTER FLUOROSCOPIC EVALUATION AND TEE CONFIRMATION OF AN EFFUSION, THE SURGEON WAS NOTIFIED AND RESCUE PROTOCOL WAS INITIATED. A STERNOTOMY WAS PERFORMED AND AN INJURY IN THE IVC (JUNCTION OF LOWER RA AND IVC JUNCTION) WAS FOUND AND REPAIRED. THE ICD LEAD WAS CUT AND CAPPED AND AN EPICARDIAL LEAD WAS PLACED BY THE SURGEON. THE PATIENT WILL BE FURTHER ASSESSED FOR A NEW RV ICD LEAD AT A LATER DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    727015 SPECTRANETICS GLIDELIGHT LASER SHEATH 16F GLIDELIGHT MFA SPECTRANETICS CORPORATION 500-303 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Hospitalization| L| R SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM| SPECTRANETICS LEAD LOCKING DEVICE (LLD)| MEDTRONIC 6947 SPRINT QUATTRO RV ICD (IMPL 132 MO)