BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECTRANETICS LEAD LOCKING DEVICE

    MDR report key: 4932645 · Received July 22, 2015

    Report

    Report Number
    1721279-2015-00110
    Event Type
    Injury
    Date Received
    July 22, 2015
    Date of Event
    July 9, 2015
    Report Date
    July 14, 2015
    Manufacturer
    SPECTRANETICS CORPORATION
    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

    (B)(4).

    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.

    Description of Event or Problem · 1

    THIS WAS A RIGHT-SIDED LEAD EXTRACTION PROCEDURE TO REMOVE ONE RA LEAD (SJM 1474T, IMPL 135 MONTHS) AND ONE RV LEAD (SJM 1452T, IMPL 135 MONTHS) DUE TO INFECTION. BOTH LEADS WERE PREPPED WITH LLD-EZS. THE PHYSICIAN STARTED THE EXTRACTION OF RA LEAD USING A 12F SLS BUT THE PROGRESS STOPPED, SO HE SWITCHED TO THE RV LEAD. WHEN THE 12F SLS WAS INSERTED INTO THE SUBCLAVIAN VEIN (NO LASING), THE PATIENT¿S BLOOD PRESSURE DECREASED GRADUALLY TO 60/30. THERE WAS NO INDICATION OF AN INJURY AND THE PRESSURE INCREASED ON ITS OWN, SO THE PROCEDURE WAS CONTINUED. THE DEVICE WAS PROGRESSED UP TO SVC AND STOPPED. A COOK MECHANICAL SHEATH WAS THEN USED AND IT PROGRESSED TO THE RIGHT ATRIUM. AT THAT TIME, THE RV LEAD CAME FREE. AT THIS TIME, THE PATIENT¿S BLOOD PRESSURE DECLINED AGAIN TO 60/30 AND A SMALL EFFUSION WAS CONFIRMED USING TEE. A PERICARDIOCENTESIS WAS PERFORMED AND APPROXIMATELY 70CC OF FLUID WAS DRAINED. THE PATIENT¿S BLOOD PRESSURE THEN INCREASED TO 100/50 AFTER THE INTERVENTION. THE PROCEDURE WAS CONTINUED USING A 12F SLS II ON THE RA LEAD WITH PROGRESSION TO THE PROXIMAL COIL. THE PHYSICIAN THEN UPSIZED TO A 14F SLS II AND THE LEAD WAS EXTRACTED WITHOUT ANY FURTHER ISSUE. THE PATIENT RECOVERED FROM THE PROCEDURE AND WAS DISCHARGED. IT IS NOT KNOWN WHERE THE INJURY WAS LOCATED. AS THE INJURY WAS ABLE TO BE TREATED WITH A LESS INVASIVE TREATMENT AND WAS NOT MORE SEVERE IN NATURE, IT IS HIGHLY SUSPECT THAT THE INJURY OCCURRED AS THE LEAD PULLED FREE FROM THE MYOCARDIUM (RV PERFORATION). IT IS BECAUSE OF THIS THAT WE ARE ATTRIBUTING THE INJURY TO THE LLD AS IT WAS THE TRACTION PLATFORM BEING USED TO PULL THE LEAD FREE FROM THE MYOCARDIUM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    474776 SPECTRANETICS LEAD LOCKING DEVICE LLD-EZ DRB SPECTRANETICS CORPORATION 518-062 FLP15B25A

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Hospitalization| L| R SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM| SPECTRANETICS LEAD LOCKING DEVICE (LLD-EZ)| SPECTRANETICS 12F SLS II LASER SHEATH| SPECTRANETICS 14F SLS II LASER SHEATH| COOK MECHANICAL SHEATH