BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GLIDELIGHT LASER SHEATH

    MDR report key: 2770381 · Received October 3, 2012

    Report

    Report Number
    1721279-2012-00118
    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
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE DISCARDED AFTER USE.

    Description of Event or Problem · 1

    THIS WAS A LEFT-SIDED CARDIAC LEAD EXTRACTION CONDUCTED IN THE HYBRID OR SUITE TO REMOVE A NON-FUNCTIONAL, FRACTURED MDT 6949 FIDELIS RV - 84MTHS OLD. THE PATIENT WAS PLACED UNDER GENERAL ANESTHESIA, ARTERIAL LINE PLACED, BOTH FLUOROSCOPY AND TEE IN USE, BLOOD PRODUCTS IN THE ROOM, AND CVS ON CALL. THE POCKET WAS OPENED AND SIGNIFICANT CALCIFICATION NOTED DURING PREP. THE RV LEAD WAS CUT, A STYLET PLACED AND AN UNSUCCESSFUL ATTEMPT WAS MADE TO DISENGAGE THE DISTAL SCREW OF THE LEAD. WHILE REMOVING THE STYLET IT WAS NOTED THE LUMEN OF THE LEAD WAS PULLED BACK, BUT THE MD WAS SUCCESSFUL AT INSERTING THE LLD-EZ TO THE DISTAL TIP OF THE FIDELIS. LASING BEGAN WITH A 14F GLIDELIGHT LASER SHEATH. ADVANCING JUST PRIOR TO THE PROXIMAL COIL THE CVX-300 EXCIMER LASER PRODUCED A 'FC-4'. THE 14F GLIDELIGHT SHEATH WAS REMOVED FROM THE PATIENT, WIPED FREE OF BLOOD, SUCCESSFULLY RE-CALIBRATED, AND RE-INSERTED INTO THE PATIENT. LASING RESUMED OVER THE PROXIMAL COIL MEETING RESISTANCE AT THE DISTAL PORTION OF THE COIL. LASING SLOWED BUT CONTINUED PAST THE DISTAL TIP OF THE COIL AGAIN MEETING RESISTANCE. IT WAS THOUGHT THE INSULATION OF THE LEAD MAY HAVE BEEN 'SNOWPLOWING' BUT THERE WAS NO RADIOLOGICAL EVIDENCE TO SUPPORT THIS. THE MD COMBINED FORWARD PROGRESSION OF THE LASER WITH MODERATE TRACTION OF THE LLD-EZ FOR APPROXIMATELY 15 SECONDS IN THE RA. JUST PRIOR TO REACHING THE PROXIMAL PORTION OF THE DISTAL COIL THE MDT 6949 'POPPED FREE' AND LEAD RECOIL WAS NOTED VIA FLUOROSCOPY. UPON EXAMINATION OF THE LEAD THERE WAS 1.5" OF FIBROSED TISSUE ADHERED TO THE PROXIMAL COIL AND LEAD INSULATION INTACT. THE MD PULLED BACK THE TEE FOR BETTER VISUALIZATION AND A SMALL EFFUSION WAS NOTED IN THE RA. APPROXIMATELY 1 MINUTE LATER THE ANESTHESIOLOGIST REPORTED THE PATIENT'S ABP HAD DROPPED INTO THE 40'S. THE CVS WAS PAGED, THE MD PERFORMED A PERICARDIOCENTESIS WITH A NEGATIVE RETURN AND CPR WAS STARTED. WITHIN 7 MINUTES OF THE INITIAL ABP DECLINE THE CVS ENTERED THE ROOM AND WITHIN 10 MINUTES AN EMERGENT STERNOTOMY WAS PERFORMED. WITHIN 12 MINUTES THE CVS SECURED THE INJURY SITE AND THE PATIENT WAS PLACED ON BYPASS WITHIN 20 MINUTES AND THE ABP INCREASED TO ~70. WITHIN ~35 MINUTES FROM THE INITIAL ABP DECLINE THE CVS SUCCESSFULLY REPAIRED THE 1.5" INNOMINATE/SVC TEAR. THE PATIENT WAS TRANSFERRED TO THE ICU AND REMAINS IN A 48HR, HYPOTHERMIA-INDUCED RECOVERY STATE. PATIENT UPDATE: AS OF (B)(6) 2012 THE PATIENT WAS REPORTED TO HAVE BEEN SUCCESSFULLY AWAKENED AND EXTUBATED WITH NO NEUROLOGICAL DEFICIENCIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GLIDELIGHT LASER SHEATH 14F GLIDELIGHT MFA SPECTRANETICS CORPORATION 500-302 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR Hospitalization| L| R CVX-300 EXCIMER LASER| LLD-EZ| MDT 6949 FIDELIS ICD LEAD