BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LEAD LOCKING DEVICE

    MDR report key: 2842573 · Received November 21, 2012

    Report

    Report Number
    1721279-2012-00165
    Event Type
    Injury
    Date Received
    November 21, 2012
    Date of Event
    November 9, 2012
    Report Date
    November 9, 2012
    Manufacturer
    SPECTRANETICS CORPORATION
    Product Code
    DRB
    PMA / PMN Number
    K043401
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THIS WAS A REPORTED LEAD EXTRACTION OF 2 LEADS (VIATRON RA & RV UNKNOWN MODEL #S; 108 MTHS OLD) CONDUCTED IN THE OR DUE TO AN ACUTE INFECTION. PRE-OPERATIVE TEE REVEALED A PRE-EXISTING RA LEAD PERFORATION, BUT THE DECISION WAS MADE TO CONTINUE WITH THE VENOUS EXTRACTION METHOD. THE PATIENT WAS INTUBATED, PREPPED PER HRS SUGGESTED GUIDELINES, BASELINE ABP WAS 125/80, AND A CVS WAS SCRUBBED INTO THE CASE. THE RV LEAD WAS PREPPED WITH A LLD-EZ AND MANUALLY EXTRACTED WITHOUT ISSUE. THE RA LEAD WAS PREPPED WITH A LLD-EZ AND LASING BEGAN WITH A 14F GLIDELIGHT SHEATH. THE MD LASED FOR APPROXIMATELY 1 SECOND STOPPING AT THE INNOMINATE/SVC JUNCTION, THEN ADVANCED THE LASER SHEATH JUST PRIOR TO THE DISTAL TIP OF THE LEAD WITHOUT LASER ENERGY. AT THIS POINT THE MD PLACED INCREASED COUNTER-TRACTION ON THE LLD-EZ AND THE RA RELEASED INTO THE 14F GL SHEATH. ALMOST IMMEDIATELY THE PATIENT'S ABP DECLINED TO 50/30. TEE CONFIRMED AN EFFUSION AND THE CVS PERFORMED A SUB-XIPHOID WINDOW WITHIN 1 MINUTES OF THE INITIAL ABP DECLINE. THE CVS UNABLE TO ACCESS THE INJURY SITE CONVERTED TO A FULL STERNOTOMY. UPON OPENING THE CHEST IT WAS NOTED THAT A COLLATERAL VEIN, ATTACHED TO THE STERNAL NOTCH WAS LACERATED DURING THE STERNOTOMY. BLEEDING WAS SUCCESSFULLY CONTROLLED ON THIS VEIN, THE PATIENT WAS PLACED ON A CELL SAVER UNIT AND 3 SMALL PERFORATIONS WERE NOTED IN THE RA. THE MD NOTED THE RA LEAD HAD 2 DISTINCT WINGS THAT EXTENDED BEYOND THE DISTAL TIP OF THE LEAD AND THIS ACCOUNTED FOR THE OTHER 2 SMALL PERFORATIONS THAT DID NOT REQUIRE SUTURING. TWO SUTURES WERE PLACED IN THE RA AND ATTENTION WAS TURNED BACK TO THE REPAIR OF THE COLLATERAL VEIN WHICH TOOK APPROXIMATELY 40 MINUTES TO COMPLETE. THE SURGICAL REPAIR WAS SUCCESSFUL; THE PATIENT WAS STABILIZED AND TRANSFERRED TO THE ICU FOR RECOVERY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Hospitalization| L| R CVX-300 EXCIMER LASER| VIATRON RV PACING LEAD: (UNKNOWN MODEL#)| LLD-EZ| VIATRON PASSIVE FIXATION: (UNKNOWN MODEL#)| 14F GLIDELIGHT