BEUDAMED
    FDA Adverse Event Death Summary report: N

    SPECTRANETICS GLIDELIGHT LASER SHEATH

    MDR report key: 3841671 · Received May 30, 2014

    Report

    Report Number
    1721279-2014-00080
    Event Type
    Death
    Date Received
    May 30, 2014
    Date of Event
    May 20, 2014
    Report Date
    May 20, 2014
    Manufacturer
    SPECTRANETICS CORPORTATION
    Product Code
    MFA
    PMA / PMN Number
    P960042
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ACCORDING TO INFORMATION RECEIVED BY SPNC THE FACILITY IS RETAINING THE DEVICE; A FOLLOW UP WILL BE PROVIDED IF THE FACILITY RELEASES THE GLIDELIGHT TO SPNC FOR EVALUATION.

    Description of Event or Problem · 1

    LEAD MANAGEMENT CASE TO REMOVE FOUR LEADS. THE PHYSICIAN PREPPED THE (B)(4) (IMPL. 2003) WITH AN LLD EZ AND A 12F GLIDELIGHT WAS USED FOR 7 SECONDS UNTIL THE LEAD RELEASED. A WHOLEY WIRE WAS PLACED THROUGH THE GLIDELIGHT TO RETAIN ACCESS FOR RE-IMPLANT AND THE GLIDELIGHT WAS REMOVED WITHOUT CONCERN. THE PHYSICIAN THEN PREPPED THE (B)(4) (IMPL. 2005) WITH AN LLD EZ AND LASED WITH A 14F GLIDELIGHT INTO THE AREA OF THE SVC. VERY LITTLE OR NO RESISTANCE WAS MET AND THE PHYSICIAN MANUALLY ADVANCED THROUGH THE VALVE AND LASED ONLY AT THE PROXIMAL END OF THE RV COIL. MANUAL ADVANCEMENT AND COUNTER TRACTION WERE USED TO FREE THE LEAD TIP. DURING THIS TIME THE PATIENT'S BP DROPPED. THE PHYSICIAN DECIDED TO GIVE THE PATIENT A PERIOD OF REST FROM PULLING BACK ON THE VENTRICLE, ALLOWING THE PATIENT BLOOD PRESSURE TO INCREASE SLIGHTLY AND STABILIZE. THE PHYSICIAN THEN REMOVED THE GLIDELIGHT; THIS ACTION CAUSED THE PATIENT'S BLOOD PRESSURE TO DROP AGAIN. AN ATTEMPT WAS MADE TO PLACE A SHEATH FOR AN RV PACING LEAD TO RAISE THE BP AND ANESTHESIA WAS INSTRUCTED TO COMMENCE TREATMENT TO RAISE THE PATIENT'S BLOOD PRESSURE. THE PATIENT'S BLOOD PRESSURE DID RESPOND TO TREATMENT AND ONCE AGAIN STABILIZED. THE PHYSICIAN CONTINUED TO HAVE DIFFICULTY WHILE ATTEMPTING TO GET THE SHEATH OVER THE ACCESS WIRE SO A VENOGRAM WAS DONE SHOWING AN AREA OF OCCLUSION AS WELL AS A DISSECTION AT THE SVC AREA. BLOOD WAS HUNG AND A STERNOTOMY WAS PERFORMED, SEVERAL LARGE CLOTS WERE FOUND IN THE THORAX UPON OPENING THE CHEST AND THE PHYSICIAN USED HIS FINGER TO TAMPONADE THE TEAR SO CARDIAC MASSAGE COULD BE PERFORMED WHILE THE PHYSICIAN CONTINUED TO REMOVE LARGE AMOUNTS OF BLOOD FROM THE THORAX. REPAIR OF THE VESSEL WAS STARTED; HOWEVER, THE PATIENT CONTINUED TO DECLINE AND DID NOT SURVIVE THE INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    318079 SPECTRANETICS GLIDELIGHT LASER SHEATH 14F GLIDELIGHT MFA SPECTRANETICS CORPORTATION 500-302 FGB13B28B

    Patients

    Seq Age Sex Outcome Treatment
    1 89 YR Death MDT ATTAIN 4193 CARDIAC LEAD (IMPL. 151 MO)| MDT SPRINT FIDELIS 6949 CARDIAC LEAD (IMPL. 111MO)| COVIDIEN WHOLEY GUIDE WIRE| SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM| SPECTRANETICS 12F GLIDELIGHT LASER SHEATH| SPECTRANETICS LEAD LOCKING DEVICE X2| MDT 5554 CAPSURE Z NOVUS CARDIAC LEAD (IMPL.151MO)| MDT 5554 CAPSURE Z NOVUS CARDIAC LEAD (IMPL.151MO)