BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GLIDELIGHT LASER SHEATH

    MDR report key: 2831904 · Received November 14, 2012

    Report

    Report Number
    1721279-2012-00159
    Event Type
    Injury
    Date Received
    November 14, 2012
    Date of Event
    November 1, 2012
    Report Date
    November 1, 2012
    Manufacturer
    SPECTRANETICS CORPORATION
    Product Code
    MFA
    PMA / PMN Number
    P960042
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THIS WAS A LEFT-SIDED LEAD EXTRACTION PROCEDURE CONDUCTED IN THE OR TO REMOVE A TOTAL OF 3 LEADS (MDT 4193 ATTAIN OTW IS-1 UNIPOLAR - LV; MDT 6944 SPRINT QUATTRO DF-1, IS-1 QUADRIPOLAR PASSIVE - RV; MDT 5076 CAPSUREFIX NOVUS IS-1 BIPOLAR SCREW - RA; ALL 84MTHS OLD) DUE TO AN INFECTION WITH LEAD EROSION. THE PATIENT WAS INTUBATED, BOTH ARTERIAL AND FEMORAL LINES PLACED, FLUOROSCOPY IN USE, AND CVS WAS SCRUBBED INTO THE CASE. THE MD PREPPED THE LV LEAD WITH A LLD-E, MANUAL TRACTION APPLIED AND THE LEAD RELEASED BUT BECAME CAUGHT IN THE OSTIUM. A 12F GLIDELIGHT WAS USED TO SUCCESSFULLY EXTRACT THE LV. BOTH THE RA AND RV LEADS WERE PREPPED WITH LLD-EZS AND LASING BEGAN ON THE RV LEAD WITH A 16F GLIDELIGHT. THE MD ALSO ATTACHED A COOK BULLDOG LEAD EXTENDER TO THE RV LEAD. LASING PROGRESSED TO HALFWAY DOWN THE DISTAL COIL UNTIL MEETING SIGNIFICANT BINDING WITH NO FORWARD MOVEMENT. THE MD CHOSE TO SWITCH TO THE RA LEAD, LASING WITH THE 16F GLIDELIGHT. FURTHER BINDING WAS ENCOUNTERED IN THE INNOMINATE AND APPROXIMATELY HALF WAY DOWN THE INNOMINATE THE PATIENT'S ABP DROPPED SIGNIFICANTLY. FLUOROSCOPY CONFIRMED AN EFFUSION AND THE CVS STEPPED IN AND PERFORMED A STERNOTOMY WITHIN 3 MINUTES, HAVING OPEN HEART ACCESS WITHIN 5 MINUTES OF THE INITIAL ABP DROP. UPON OPENING THE CHEST AN APPROXIMATE 6CM TEAR FROM THE INNOMINATE TO THE RA JUNCTION. THE PATIENT WAS PLACED ON BYPASS AND THE SURGICAL REPAIR OF THE TEAR WAS SUCCESSFUL. THE PATIENT WAS STABILIZED AND TRANSPORTED TO ICU FOR RECOVERY. AS OF (B)(6) 2012, THE MD REPORTED THE PATIENT AS "DOING WELL" AND REMAINS HOSPITALIZED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GLIDELIGHT LASER SHEATH 16F GLIDELIGHT MFA SPECTRANETICS CORPORATION 500-303 FGC12F22C

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Hospitalization| L| R MDT 4193 ATTAIN OTW IS-1 UNIPOLAR| MDT 5076 CAPSUREFIX NOVUS IS-1 BIPOLAR SCREW| COOK BULLDOG LEAD EXTENDER| LLD-EZ| CVX-300 EXCIMER LASER| MDT 6944 SPRINT QUATTRO DF-1| 12F GLIDELIGHT| LLD-E