BEUDAMED
    FDA Adverse Event Death Summary report: N

    EKOSONIC ENDOVASCULAR CATHETER

    MDR report key: 5686381 · Received May 27, 2016

    Report

    Report Number
    3001627457-2016-00014
    Event Type
    Death
    Date Received
    May 27, 2016
    Date of Event
    May 6, 2016
    Report Date
    April 28, 2016
    Manufacturer
    EKOS CORPORATION
    Product Code
    KRA
    PMA / PMN Number
    K140151
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS CASE IS REPORTABLE DUE TO THE INTRACRANIAL HAEMORRHAGE WHICH OCCURRED SHORTLY AFTER THE PROCEDURE, AND WHICH IS LIKELY TO BE ASSOCIATED WITH TPA THERAPY. THE DEVICES WERE NOT RETURNED TO EKOS FOR EVALUATION. TWO DEVICES WERE USED CONCURRENTLY DURING THIS PROCEDURE. INFORMATION ON THE SECOND DEVICE IS AS FOLLOWS: CATALOG #: 500-56112, SERIAL #: (B)(4), EXPIRATION DATE: 02/06/2019, DATE OF MANUFACTURE: 03/02/2016. DEVICES WERE NOT RETURNED FOR EVALUATION.

    Additional Manufacturer Narrative · 1

    CORRECTED REPORT DATE TO 04/28/2016.

    Description of Event or Problem · 1

    ON (B)(6) 2016, THIS (B)(6)-YEAR-OLD CAUCASIAN MALE PATIENT WITH A PAST MEDICAL HISTORY OF ACCELERATED HYPERTENSION, IDIOPATHIC THROMBOCYTOPENIA, HYPERCHOLESTEROLEMIA AND PANCYTOPENIA SECONDARY TO BONE MARROW HYPO CELLULARITY PRESENTED TO THE HOSPITAL. THE PATIENT WAS REPORTED AS HAVING NO RECENT HISTORY OF TOBACCO, ALCOHOL OR DRUG ABUSE. THE PATIENT WAS ADMITTED TO HOSPITAL DUE TO WORSENING DYSPNOEA ON EXERTION WHILST RUNNING, FLUSHING OF THE FACE, CHEST PAIN AND DIAPHORESIS. THE PATIENT ALSO REPORTED EXPERIENCING DRYNESS AND SLIGHT TIGHTNESS IN HIS THROAT AS WELL AS GENERALIZED WEAKNESS. THE PATIENT'S SYMPTOMS WERE REPORTED AS HAVING BEGUN FOUR (4) DAYS PRIOR TO ADMISSION. ON ADMISSION, THE REPORTER STATED THAT THE PATIENT WAS AFEBRILE WITH OXYGEN SATURATION 88% AND BLOOD PRESSURE 148/74. A COMPUTED TOMOGRAPHY (CT) ANGIOGRAM OF THE CHEST SHOWED EVIDENCE OF EXTENSIVE BILATERAL PULMONARY EMBOLI (PE), TRACE PERICARDIAL FLUID AND MILDLY EMPHYSEMATOUS AND HYPER-INFLATED LUNGS. THE PATIENT WAS INITIALLY TREATED WITH ENOXAPARIN (DOSAGE NOT REPORTED). THE PATIENT WAS SUBSEQUENTLY DIAGNOSED WITH BILATERAL SUBMASSIVE PE AND RIGHT VENTRICULAR DYSFUNCTION WITH RIGHT VENTRICULAR/LEFT VENTRICULAR RATIO OF 1.33 AND ENROLLED INTO THE (B)(6) CLINICAL STUDY ON (B)(6) 2016. ON (B)(6) 2016, THE PATIENT UNDERWENT TREATMENT WITH THE EKOSONIC ENDOVASCULAR CATHETER FOR PULMONARY EMBOLISM, WITH SELECTIVE PLACEMENT OF EKOS CATHETERS IN THE RIGHT MAIN PULMONARY, RIGHT LOWER LOBE PULMONARY, LEFT MAIN PULMONARY AND LEFT LOWER LOBE PULMONARY ARTERIES. IT WAS REPORTED THAT ON (B)(6) 2016, THE PATIENT WAS NOTED TO HAVE ACUTE ONSET OF RIGHT LOWER FACIAL DROOP AND RIGHT-SIDED WEAKNESS. A CT OF THE BRAIN PERFORMED WITHOUT CONTRAST SHOWED LEFT-SIDED PARENCHYMAL HAEMORRHAGE INVOLVING THE LEFT FRONTOPARIETAL CONVEXITY WITH SLIGHT SUBARACHNOID EXTENSION MEASURING 34 MM. THE PATIENT WAS EXHIBITING SLURRING OF SPEECH. THE PATIENTS' BLOOD PRESSURE WAS REPORTED AS BEING LABILE, RANGING FROM 116/57 TO 181/92. ON (B)(6) 2016, A REPEAT CT OF THE BRAIN PERFORMED WITHOUT CONTRAST SHOWED EVOLVING PARENCHYMAL HEMATOMA IN THE LEFT FRONTOPARIETAL CONVEXITY WITH SMALL SURROUNDING EDEMA. THE SIZE OF THE HEMATOMA HAD INCREASED SINCE THE PRIOR CT PERFORMED ON (B)(6) 2016 (SIZE NOT REPORTED) BUT APPEARED STABLE. AN MRI OF THE BRAIN SHOWED THE SUBJECT HAD CAVERNOUS MALFORMATION OR POSSIBLE ACUTE HAEMORRHAGE. LABORATORY RESULTS INCLUDED INR 1.1 AND PTT 33.7 SEC. THE PATIENT'S ANTICOAGULATION THERAPY WAS SUSPENDED. THE PATIENT UNDERWENT THOROUGH DIAGNOSTIC EVALUATION; HOWEVER, NO OBVIOUS UNDERLYING CAUSE FOR THE INTRACRANIAL HAEMORRHAGE (ICH) COULD BE IDENTIFIED. THE REPORTED STATED THAT THE ICH MOST LIKELY WAS DUE TO THE SYSTEMIC EFFECT OF ANTICOAGULATION AND PROBABLE INTRAVENOUS THROMBOLYSIS. ON (B)(6) 2016, THE PATIENTS SLURRING OF SPEECH WAS REPORTED AS HAVING IMPROVED WITH PHYSICAL THERAPY AND THE PATIENTS' LEFT FRONTOPARIETAL HAEMORRHAGE APPEARED TO BE STABLE. ON (B)(6) 2016, THE PATIENT UNDERWENT 2D ECHO WHICH REVEALED QUESTIONABLE RIGHT ATRIAL THROMBUS. THE PATIENT'S STATUS WAS REPORTED AS ALERT AND FOLLOWING COMMANDS WITH NO FOCAL NEUROLOGICAL DEFICIT. ANTICOAGULATION THERAPY WAS NOT ADMINISTERED DUE TO ICH WHICH WAS REPORTED AS SLOWLY IMPROVING. ON (B)(6) 2016, THE PATIENT'S CONDITION WAS REPORTED AS REMAINING CLINICALLY STABLE, HE WAS AMBULATORY AND DISCHARGED TO REHAB. THE PATIENT COMMENCED PHYSICAL THERAPY AT THE REHABILITATION FACILITY (B)(6) 2016, THE REPORTER STATED THAT THE PATIENT WAS ABLE TO PARTICIPATE IN EVALUATION PROCEDURES WITHOUT AND C/O PAIN OR DISCOMFORT. ASSESSMENT OF THE PATIENTS 'HAND HELD' GAIT TECHNIQUE WAS PERFORMED WITH THE PATIENT AMBULATING 100FT PRIOR TO BEING ASSISTED BACK INTO HIS WHEELCHAIR. THE PATIENT STATED THAT 'IT FELT GOOD TO WALK WITH HAND HELD X2 INSTEAD OF AN 'RW' AS IT FELT MORE NATURAL' (VERBATIM). AS THE PATIENT CONTINUED TO SPEAK THE PHYSICAL THERAPIST NOTED THAT THE PATIENT'S EYES 'GAZED TO THE LEFT' AND THAT THE PATIENT SLUMPED INTO THE WHEEL CHAIR AND BEGAN TO EXPERIENCE A 'SEIZURE' (TIME NOTED AS APPROXIMATELY 08:45). A TONGUE DEPRESSOR WAS PROVIDED FOR THE PATIENT DURING THE SEIZURE DUE TO BITING ACTIVITY. A NURSE WAS CALLED AND WHILST THE STAFF WERE ARRIVING TO ASSIST, THE PATIENT WAS REPORTED TO HAVE RESPONDED TO STAFF ASKING IF HE WAS ALRIGHT BY SAYING 'OK'. HOWEVER, SHORTLY THEREAFTER, THE PATIENT EXPERIENCED A FURTHER SEIZURE. THE PATIENT WAS TRANSFERRED TO A HOSPITAL BED AND TRANSFERRED TO THE CARE OF THE REGISTERED NURSES. OXYGEN WAS ADMINISTERED TO THE PATIENT USING A NASAL CANNULA (3L/MIN). THE PATIENT BECAME UNRESPONSIVE AND DISPLAYED 'AGONAL TYPE' BREATHING AND DUE TO THIS THE PATIENT WAS AMBU BAGGED. A 22 GAUGE IV WAS INSERTED AND THE PATIENT'S LABS WERE RECORDED AS V/S 111/55, 80, 78% O2 SATURATION, MULTIPLE ATTEMPTS WERE MADE UNSUCCESSFULLY TO CAPTURE THE PATIENTS EKG. AN ARTIFICIAL AIRWAY WAS INSERTED WITH THE PATIENT'S OXYGEN SATURATION RECORDED AS 98% POST INSERTION. A NON-BREATHER MASK WAS PLACED, THE PATIENTS' BLOOD SUGAR LEVELS WERE REPORTED AS 166, BP 101/57, PULSE 107 AND O2 SATURATION 87%. INFUSION OF NORMAL SALINE WAS COMMENCED AT 08:58. AT 09:00 THE PATIENTS OXYGEN SATURATION WAS REPORTED AS 97% AND PULSE AT 54, AT THIS TIME, THE ARTIFICIAL AIRWAY WAS REMOVED. THE PATIENT WAS TRANSPORTED BY EMS TO THE ER, DURING TRANSFER CARDIO PULMONARY RESUSCITATION (CPR) WAS STARTED BY EMS. EMS REPORTED PATIENT PULSE WAS ABSENT DURING TRANSIT AND CARDIAC RHYTHM WAS ASYSTOLE AND V-TACH. THERE WAS BRIEF RETURN OF SPONTANEOUS CIRCULATION ON ARRIVAL AT THE HOSPITAL. THE PATIENT WAS DIAGNOSED WITH CARDIAC ARREST AND RESUSCITATION WAS CONTINUED IN ACCORDANCE WITH ACLS (ADVANCED CARDIOVASCULAR LIFE SUPPORT) ALGORITHMS WITH A CENTRAL VENOUS CATHETER PLACEMENT IN THE RIGHT FEMORAL VEIN. CPR WAS CONTINUED FOR 30 MINUTES WITHOUT RETURN OF PULSE. THE TIME OF DEATH WAS REPORTED AS 10:01 AM. AN AUTOPSY WAS NOT PERFORMED AS THE PATIENTS FAMILY REQUESTED THIS NOT BE PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    338876 EKOSONIC ENDOVASCULAR CATHETER CATHETER, CONTINUOUS FLUSH, PRODUCT CODE: KRA KRA EKOS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Death