BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECTRANETICS LASER SHEATH II

    MDR report key: 2771180 · Received October 3, 2012

    Report

    Report Number
    1721279-2012-00119
    Event Type
    Injury
    Date Received
    October 3, 2012
    Date of Event
    September 10, 2012
    Report Date
    September 10, 2012
    Manufacturer
    SPECTRANETICS CORPORATION
    Product Code
    MFA
    PMA / PMN Number
    P960042
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS DISCARDED AFTER USE.

    Description of Event or Problem · 1

    THIS WAS A LEFT-SIDED LEAD EXTRACTION CONDUCTED IN THE O.R. TO REMOVE A FRACTURED, 88 MONTH OLD SJM 1580 RIATA DUAL COIL ICD-RV. THE PATIENT ALSO HAD A PACESETTER/SJM 1688TC PACING LEAD THAT WAS NOT GOING TO BE REMOVED. THE PATIENT WAS PREPPED WITH AN ARTERIAL LINE, FLUOROSCOPY IN USE, BLOOD PRODUCTS WERE IN THE ROOM, TEE AND CVS AVAILABLE. THE SJM 1580 RIATA WAS PREPPED WITH A LLD #2/COOK BULLDOG COMBINATION AND LASING BEGAN WITH THE 16F SLS II. LASING PROGRESSED NICELY UNTIL JUST PAST THE DISTAL END OF THE DISTAL SHOCKING COIL. THE LEAD HAD A BINDING SITE DOWN THE ENTIRE DISTAL COIL AND WOULD NOT RELEASE WITH NORMAL TRACTION. THE MD MAINTAINED APPROPRIATE TRACTION ON THE ICD LEAD THROUGHOUT THE PROCEDURE. WHEN THE 16F SLS II WAS ADVANCED TO THE MIDDLE OF THE DISTAL COIL, TRACTION, WITH/WITHOUT COUNTER TRACTION, WAS APPLIED IN AN ATTEMPT TO PULL THE LEAD FREE FROM THE VASCULATURE. WHEN IT WOULD NOT RELEASE, THE LASER SHEATH WAS ADVANCED TO THE DISTAL TIP OF THE LEAD. THE RV LEAD RELEASED AND THE PATIENT'S ABP REMAINED SOMEWHAT STABLE AND THE MD RE-IMPLANTED THE NEW ICD LEAD. INSPECTION OF THE DISTAL PORTION OF THE RV LEAD SHOWED A SMALL AMOUNT OF TISSUE STILL ATTACHED TO THE SCREW, APPEARING TO BE MYOCARDIAL TISSUE. AT THE END OF THE RE-IMPLANT PROCESS, IT WAS NOTED THAT THE PATIENTS LV WAS NOT MOVING AS IT HAD BEEN PRIOR TO THE PROCEDURE. A TEE WAS INSERTED AND NOTED A PERICARDIAL EFFUSION PRESENT AROUND THE APEX OF THE HEART. THE CVS ENTERED THE OR WITHIN 3 MINUTES AND QUICKLY ASSESSED THE SITUATION. AN EMERGENT STERNOTOMY WAS PERFORMED AND AN APICAL PERFORATION WAS FOUND THAT WAS CLOTTED OFF. THE REPAIR OF THE PERFORATION WAS SUCCESSFUL AND THE PATIENT TOLERATED THE PROCEDURE WELL. THE PATIENT WAS TRANSPORTED TO THE ICU FOR RECOVERY AND WAS REPORTEDLY DISCHARGED FROM THE HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPECTRANETICS LASER SHEATH II 16F SLS II MFA SPECTRANETICS CORPORATION 500-013 CKK12C05C

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Hospitalization| L| R SJM 1580 RIATA DUAL COIL ICD| PACESETTER/SJM 1688TC PACING LEAD| CVX-300 EXCIMER LASER| LLD# 2| COOK BULLDOG LEAD EXTENDER