BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECTRANETICS LLZ EZ LEAD LOCKING DEVICE

    MDR report key: 6517526 · Received April 24, 2017

    Report

    Report Number
    1721279-2017-00072
    Event Type
    Injury
    Date Received
    April 24, 2017
    Date of Event
    April 3, 2017
    Report Date
    April 3, 2017
    Manufacturer
    SPECTRANETICS
    Product Code
    DRB
    PMA / PMN Number
    K142116
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE 510K NUMBER HAS BEEN CORRECTED TO REFLECT THE MOST CURRENT AND UP TO DATE NUMBER, AS OF THE DATE OF THE INITIAL REPORT.

    Additional Manufacturer Narrative · 1

    PATIENT WEIGHT, PRE-OP LABS/TESTING AND MEDICAL HISTORY UNKNOWN.

    Description of Event or Problem · 1

    LEAD MANAGEMENT PROCEDURE TO EXTRACT ONE RA LEAD. THE LEAD WAS PREPPED WITH A LLD-EZ. A 16F SLSII WAS ADVANCED TO NEAR SVC, THEN TO SIGNIFICANT ADHESION/CALCIFICATION, A COOK DILATOR SHEATH WAS USED TO ADVANCE TO THE SVC. THE SLSII WAS ADVANCED TO THE TIP OF THE LEAD, THEN THE LEAD WAS EXTRACTED USING COUNTERTRACTION. AT THAT TIME, THE PATIENT'S BLOOD PRESSURE WAS STABLE. THE PHYSICIAN IMPLANTED THE NEW LEAD USING THE SLSII DEVICE AND GUIDEWIRE, THEN THE SLSII DEVICE WAS REMOVED. APPROXIMATELY TWO MINUTES AFTER THE OLD LEAD WAS EXTRACTED, THE PATIENT'S BLOOD PRESSURE DROPPED AND A CARDIAC EFFUSION WAS CONFIRMED ON TEE (TRANS-ESOPHAGEAL ECHO); LOCATION OF INJURY UNKNOWN. INTERVENTION VIA PERICARDIOCENTESIS WAS PERFORMED AND PATIENT BECAME STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    299047 SPECTRANETICS LLZ EZ LEAD LOCKING DEVICE LLD DRB SPECTRANETICS 518-067 FLP15J17A

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Hospitalization| R SPECTRANETICS CVX-300 EXCIMER LASER| SPECTRANETICS SLSII LASER SHEATH