BEUDAMED
    FDA Adverse Event Death Summary report: N

    SOUNDSTAR® 3D DIAGNOSTIC ULTRASOUND CATHETER

    MDR report key: 3071558 · Received April 22, 2013

    Report

    Report Number
    2029046-2013-00052
    Event Type
    Death
    Date Received
    April 22, 2013
    Date of Event
    April 9, 2013
    Report Date
    April 9, 2013
    Manufacturer
    BIOSENSE WEBSTER, INC (IRWINDALE)
    Product Code
    OBJ
    PMA / PMN Number
    K070242
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS SUPPLEMENTAL REPORT IS IN RESPONSE TO THE FDA REQUEST DATED (B)(4) 2013 PLEASE CONFIRM OR PROVIDE THE MODEL, LOT, SERIAL#, AND/OR CATALOG NUMBER(S) OF THE DEVICE LISTED IN THE MEDICAL DEVICE REPORT AS APPLICABLE RESPONSE: WE CONFIRM THE MODEL, SERIAL AND CATALOG NUMBER PROVIDED IN THIS LETTER FOR THE DEVICE LISTED IN THE MEDICAL DEVICE REPORT. THE PRODUCT INFORMATION IS MODEL NUMBER M-5723-05, SERIAL NUMBER# (B)(4) AND CATALOG NUMBER SNDSTR10. PLEASE PROVIDE A MORE COMPLETE DESCRIPTION OF THIS EVENT INCLUDING RELEVANT EVENTS PRIOR TO AND SUBSEQUENT TO THE EVENT. RESPONSE: ALL THE AVAILABLE INFORMATION THAT WAS PROVIDED ON THE EVENT WAS INCLUDED IN THE INITIAL MDR REPORT 2029046-2013-00052 SUBMITTED ON (B)(4) 2013 UNDER EVENT DESCRIPTION. DURING AN IDIOPATHIC VT ABLATION PROCEDURE, IT WAS REPORTED THAT THE PATIENT SUFFERED A PERICARDIAL EFFUSION DURING THE ABLATION IN THE LEFT VENTRICLE OUTFLOW TRACT. IT WAS NOTICED A DROP IN PATIENT BLOOD PRESSURE FROM 130/70 TO 90/50. THE PHYSICIAN IDENTIFIED THE PERICARDIAL EFFUSION BY USING INTRACARDIAC ECHOCARDIOGRAPHY. THE PROCEDURE WAS ABORTED. PROTAMINE AND A FLUID BOLUS WERE ADMINISTERED. THE PATIENT WAS STABILIZED. BUT AFTER THE SOUNDSTAR WAS WITHDRAWN, THE PATIENT ¿CRASHED¿. A PERICARDIOCENTESIS WAS PERFORMED. APPROXIMATELY 1500 CC OF BLOOD WAS WITHDRAWN FROM THE PERICARDIAL SPACE. THE PATIENT WAS TRANSFUSED WITH RBC¿S DUE TO THE BLOOD LOSS. IT APPEARS THAT THE SOUNDSTAR CATHETER HAD PERFORATED THE RIGHT VENTRICLE AND WHEN THE CATHETER WAS REMOVED, THE PATIENT BLOOD PRESSURE DROPPED IMMEDIATELY. IT WAS LATER CONFIRMED BY THE CT SURGEON THAT THE RIGHT VENTRICLE HAD A HOLE IN IT WHEN THE HEART WAS OPENED AND EXAMINED. THE ONLY CATHETER PLACED IN THE RIGHT VENTRICLE DURING THE PROCEDURE WAS THE SOUNDSTAR CATHETER. PATIENT EXPIRED 5 HOURS POST PROCEDURE DESPITE EXTRAORDINARY EFFORTS. PLEASE PROVIDE A SUMMARY OF THE RESULTS FOR ANY INVESTIGATION, EVALUATION, AND/OR FAILURE ANALYSIS, INCLUDING ROOT CAUSE IDENTIFICATION, RELEVANT TO THE REPORTED EVENT. PLEASE INCLUDE: A COMPLETE DESCRIPTION OF METHODOLOGY(IES) USED. AN IDENTIFICATION OF THE SPECIFIC FAILURE MODE(S) AND/OR MECHANISM(S) AND THE ASSOCIATED DEVICE COMPONENT(S) INVOLVED, AND ANY CONCLUSIONS REACHED BASED ON THE INVESTIGATION AND ANALYSIS RESULTS. PLEASE PROVIDE ANY EVALUATION OF THE EVENT DESCRIBED IN THE MEDICAL DEVICE REPORT BY THE ATTENDING PHYSICIAN, SURGEON, HOSPITAL REPRESENTATIVE OR HEALTH CARE PROFESSIONAL. RESPONSE PROVIDED BY THE PHYSICIAN: BW HAS CONTACTED THE PHYSICIAN FOR THE DEATH EVENT. ACCORDING TO THE OPERATING EP PHYSICIAN, IT WAS IN THE MIDDLE OF THE ABLATION IN THE LEFT VENTRICLE, THE PATIENT¿S BLOOD PRESSURE STARTED TO DROP AND THE PERICARDIAL EFFUSION WAS NOTED. THE PHYSICIAN FIRST THOUGHT THE PERFORATION MIGHT BE AT THE LEFT VENTRICLE WHERE HE WAS ABLATING, BUT LATER IT WAS CONFIRMED BY THE SURGEON THAT THERE WAS A HOLE IN THE RIGHT VENTRICLE ANTERIOR FREE WALL WHERE THE HEART WAS PERFORATED. THE EP PHYSICIAN DID A PERICARDIOCENTESIS IN THE LAB AND LEFT THE CATHETER IN FOR DRAINAGE AND PATIENT WAS SEND TO THE ICU. IN THE ICU, THE PATIENT¿S BLOOD PRESSURE BECAME UNSTABLE AGAIN. THE CT SURGEON DECIDED TO DO THE URGENT OPEN-CHEST SURGERY IN THE ICU INSTEAD OF OR TO REPAIR THE PERFORATION. BUT EVENTUALLY THE PATIENT STILL DIED FROM UNCONTROLLED BLEEDING. IT WAS CONFIRMED BY THE PHYSICIAN THAT NO RF ABLATION HAD EVER BEEN APPLIED IN THE RIGHT VENTRICLE AND THE ONLY CATHETER PLACED IN THE RIGHT VENTRICLE WAS THE SOUNDSTAR CATHETER. THEREFORE, THE SOUNDSTAR WAS CONSIDERED THE CAUSE OF PERFORATION IN THE RV. HOWEVER, THE PHYSICIAN CONFIRMED THAT THERE IS NO EVIDENCE OF CATHETER MALFUNCTION DURING THE PROCEDURE. PLEASE PROVIDE ANY EVALUATION OF OTHER INFORMATION USED BY YOUR FIRM TO DETERMINE WHETHER THE EVENTS DESCRIBED IN THE MEDICAL DEVICE REPORT ARE OR ARE NOT ATTRIBUTABLE TO THE DEVICE. RESPONSE: IN THIS REPORTED EVENT, IT IS CLEAR, AND HAS ALSO BEEN CONFIRMED BY THE PHYSICIAN, THAT THE CARDIAC PERFORATION EVENT WAS ATTRIBUTED TO THE SOUNDSTAR CATHETER PLACED IN THE RIGHT VENTRICLE. ALTHOUGH NO CATHETER MALFUNCTION WAS OBSERVED, THE PERFORATION COULD BE CAUSED BY MANIPULATION OF THE SOUNDSTAR CATHETER IN THE RIGHT VENTRICLE. (B)(4). THE IFU STATES THAT CAREFUL CATHETER MANIPULATION MUST BE PERFORMED IN ORDER TO AVOID CARDIAC DAMAGE, PERFORATION OR TAMPONADE. PLEASE PROVIDE MORE COMPLETE PATIENT INFORMATION RELATED TO THIS EVENT SUCH AS AGE, GENDER, MEDICAL HISTORY, RELEVANT LABORATORY TEST RESULTS, PATIENT¿S SIGNS AND SYMPTOMS, AND/OR PATIENT OUTCOME. RESPONSE: PATIENT AGE AT THE TIME OF EVENT: (B)(6). PATIENT GENDER: FEMALE. PATIENT WEIGHT: (B)(6). PATIENT STATUS: PATIENT EXPIRED 5 HOURS POST PROCEDURE DESPITE EXTRAORDINARY EFFORTS. OTHER RELEVANT HISTORY: SEVERE HYPERTENSION. PLEASE PROVIDE THE PRIMARY AND SECONDARY CAUSE OF DEATH AS IT WAS REPORTED BY THE PATIENT¿S PHYSICIAN, AS IT APPEARS IN THE MEDICAL RECORD OR AS IT IS DESCRIBED IN THE AUTOPSY REPORT. PLEASE INCLUDE THE INFORMATION SOURCE USED IN YOUR RESPONSE: IN SUMMARY, THE PATIENT SUFFERED A PERICARDIAL EFFUSION DUE TO CARDIAC PERFORATION IN THE RIGHT VENTRICLE ANTERIOR FREE WALL; THE PATIENT, A FRAGILE FEMALE IN HER (B)(6), EVENTUALLY DIED FROM UNCONTROLLED BLEEDING AFTER THE EMERGENCY OPEN-CHEST SURGERY IN THE ICU. PER PHYSICIAN, NO AUTOPSY HAS BEEN DONE. (B)(4). PLEASE PROVIDE A COMPLETE LIST OF ALL RELATED MEDICAL DEVICE REPORTING (MDR) ACCESS NUMBERS AS WELL AS THE REASON FOR THEIR INCLUSION IN THE TREND. RESPONSE: (B)(4). CARDIAC PERFORATION/EFFUSION EVENTS ARE USUALLY REPORTED UNDER THE THERAPEUTIC CATHETERS SINCE THESE DEVICES ARE USED TO DELIVER THE ABLATION ENERGY TO THE PATIENT AND COULD POTENTIALLY CONTRIBUTE TO CARDIAC PERFORATION DURING CATHETER MANIPULATION. PER IFU, THE BIOSENSE WEBSTER SOUNDSTAR 3D DIAGNOSTIC ULTRASOUND CATHETER IS INDICATED FOR INTRA-CARDIAC AND INTRA-LUMINAL VISUALIZATION OF CARDIAC AND GREAT VESSEL ANATOMY AND PHYSIOLOGY AS WELL AS VISUALIZATION OF OTHER DEVICES IN THE HEART. FOR REPORT 2029046-2012-00050 AND REPORT 2029046-2013-00046, BWI DECIDED TO REPORT THESE EVENTS UNDER THE SOUNDSTAR CATHETER SINCE THE CUSTOMER SUSPECTED THE SOUNDSTAR CATHETER COULD HAVE POTENTIALLY CONTRIBUTED TO THE EVENT. FOR REPORT 2936884-2011-00001, BWI DECIDED TO REPORT THIS EVENT UNDER THE SOUNDSTAR CATHETER SINCE THE SOUNDSTAR CATHETER USED IN THE PROCEDURE WAS THE ONLY BWI CATHETER USED. THE OTHER CATHETER USED WAS A NON-BWI PRODUCT. THE PHYSICIAN DID NOT STATE WHETHER THE EVENT¿S CAUSALITY WAS DUE TO THE SOUNDSTAR CATHETER OR THE NON-BWI CS CATHETER. FOR REPORT 2936884-2011-00001 AND 2029046-2013-00046, THE SOUNDSTAR CATHETERS WERE EVALUATED AND THERE WERE NO CATHETER MALFUNCTION IDENTIFIED. FOR REPORT 2029046-2012-00050, THE DEVICE WAS NOT RETURNED FOR FURTHER EVALUATION. WHAT FACTORS MAY BE CONTRIBUTED TO THE CARDIAC PERFORATION? DID THE PHYSICIAN HAVE PRIOR KNOWLEDGE OF THIS DEVICE? HAVE ANY ACTIONS BEEN TAKEN TO ADDRESS THIS COMPLAINT? RESPONSE A: ACCORDING TO THE PHYSICIAN, IT IS MOST LIKELY THAT MANIPULATION OF THE SOUNDSTAR CATHETER INSIDE OF THE RIGHT VENTRICLE MIGHT CONTRIBUTED TO THE CARDIAC PERFORATION, AS IT WAS EVIDENT THERE WAS A HOLE IN THE RV AND THE SOUNDSTAR CATHETER WAS THE ONLY CATHETER PLACED IN THE RV. IN ADDITION, PHYSICIAN STATED NO CATHETER MALFUNCTION OR ISSUES WITH ANY OF THE BWI PRODUCTS WAS NOTICED DURING THE PROCEDURE. RESPONSE B: (B)(4). RESPONSE C: BASED ON THE PHYSICIAN RESPONSE IT IS MOST LIKELY THAT MANIPULATION OF THE SOUNDSTAR CATHETER INSIDE OF THE RIGHT VENTRICLE MIGHT CONTRIBUTED TO THE CARDIAC PERFORATION. PHYSICIAN STATED NO CATHETER MALFUNCTION OR ISSUES WITH ANY OF THE BWI PRODUCTS WAS NOTICED DURING THE PROCEDURE. IN ADDITION THE DEVICE WAS RETUNED AND IT WAS ALSO CONFIRMED THERE WAS NO MALFUNCTION WITH THE SOUNDSTAR CATHETER. THEREFORE NO FURTHER ACTIONS HAVE BEEN TAKEN TO ADDRESS THIS COMPLAINT AT THIS TIME. (B)(4). DURING THE IDIOPATHIC VT ABLATION PROCEDURE, IT WAS REPORTED THAT THE PATIENT SUFFERED A PERICARDIAL EFFUSION DURING A LEFT VENTRICLE OUTFLOW TRACT PVC ABLATION. IT WAS NOTICED A DROP IN PATIENT BLOOD PRESSURE FROM 130/70 TO 90/50. THE PHYSICIAN IDENTIFIED A PERICARDIAL EFFUSION BY USING INTRACARDIAC ECHOCARDIOGRAPHY. THE PROCEDURE WAS ABORTED. PROTAMINE AND A FLUID BOLUS WERE ADMINISTERED. THE PATIENT WAS STABLE. ADDITIONAL INFORMATION PROVIDED STATED, PERICARDIOCENTESIS WAS PERFORMED AFTER THE SOUNDSTAR CATHETER WAS WITHDRAWN. APPROXIMATELY 1500 CC OF BLOOD WAS WITHDRAWN FROM THE PERICARDIAL SPACE. THE PATIENT WAS TRANSFUSED WITH RBC¿S DUE TO THE BLOOD LOSS. IT APPEARS THAT THE SOUNDSTAR CATHETER HAD PERFORATED THE RIGHT VENTRICLE AND WHEN THE CATHETER WAS REMOVED, THE PATIENT BLOOD PRESSURE DROPPED IMMEDIATELY. IT WAS LATER CONFIRMED BY A CT SURGEON THAT THE RIGHT VENTRICLE HAD A HOLE IN IT WHEN THE HEART WAS OPENED AND EXAMINED. THE ONLY CATHETER PLACED IN THE RIGHT VENTRICLE WAS THE SOUNDSTAR CATHETER. PATIENT EXPIRED 5 HOURS POST PROCEDURE. THE CATHETER WAS TESTED FOR EEPROM, CARTO 3 AND CALIBRATION FUNCTIONALITY. THE CATHETER WAS RECOGNIZED BY CARTO 3 SYSTEM, NO ERROR MESSAGES WERE DISPLAYED AND THE CATHETER WAS PROPERLY VISUALIZED. EEPROM DATA DEMONSTRATES THE CATHETER WAS PROPERLY CALIBRATED DURING MANUFACTURING. THE CATHETER WAS ALSO TESTED FOR TRANSDUCER FUNCTIONALITY. THE TESTING REVEALED THE TRANSDUCER ELEMENTS WERE IN GOOD CONDITIONS SINCE THEIR SENSITIVITY AND CAPACITANCE PASSED THIS TEST. FINALLY, A DEFLECTION TEST WAS PERFORMED AND THE CATHETER PASSED. THE DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO ANOMALIES WERE FOUND RELATED TO THIS COMPLAINT. IN ADDITION, THE DHR REVIEW VERIFIES THAT THE DEVICE WAS MANUFACTURED IN ACCORDANCE WITH DOCUMENTED SPECIFICATION AND PROCEDURES. THE CATHETER PASSED ALL SPECIFICATIONS. THE ROOT CAUSE OF THE PERICARDIAL EFFUSION REMAINS UNKNOWN. THE IFU STATES THAT CAREFUL CATHETER MANIPULATION MUST BE PERFORMED IN ORDER TO AVOID CARDIAC DAMAGE, PERFORATION OR TAMPONADE.

    Additional Manufacturer Narrative · 1

    ADD'L MEDICAL DEVICES: CARTO 3 SYSTEM, MODEL #: M-4800-01, SERIAL #: (B)(4); STOCKERT 70 SYSTEM, MODEL #: M-5463-01, SERIAL #: (B)(4); COOL FLOW PUMP, MODEL #: M-5491-02, SERIAL #: (B)(4); EZ STEER THERMOCOOL SF NAV, MODEL #: D-1317-04-S, LOT #: 15814125L. (B)(4).

    Description of Event or Problem · 1

    DURING THE IDIOPATHIC VT ABLATION PROCEDURE, IT WAS REPORTED THAT THE PATIENT SUFFERED A PERICARDIAL EFFUSION DURING A LEFT VENTRICLE OUTFLOW TRACT PVC ABLATION. IT WAS NOTICED A DROP IN PATIENT BLOOD PRESSURE FROM 130/70 TO 90/50. THE PHYSICIAN IDENTIFIED A PERICARDIAL EFFUSION BY USING INTRACARDIAC ECHOCARDIOGRAPHY. THE PROCEDURE WAS ABORTED. PROTAMINE AND A FLUID BOLUS WERE ADMINISTERED. THE PATIENT WAS STABLE. ADDITIONAL INFORMATION PROVIDED STATED, PERICARDIOCENTESIS WAS PERFORMED AFTER THE SOUNDSTAR CATHETER WAS WITHDRAWN. APPROXIMATELY 1500 CC OF BLOOD WAS WITHDRAWN FROM THE PERICARDIAL SPACE. THE PATIENT WAS TRANSFUSED WITH RBC'S DUE TO THE BLOOD LOSS. IT APPEARS THAT THE SOUNDSTAR CATHETER HAD PERFORATED THE RIGHT VENTRICLE AND WHEN THE CATHETER WAS REMOVED, THE PATIENT BLOOD PRESSURE DROPPED IMMEDIATELY. IT WAS LATER CONFIRMED BY A CT SURGEON THAT THE RIGHT VENTRICLE HAD A HOLE IN IT WHEN THE HEART WAS OPENED AND EXAMINED. THE ONLY CATHETER PLACED IN THE RIGHT VENTRICLE WAS THE SOUNDSTAR CATHETER. PATIENT EXPIRED 5 HOURS POST PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    171283 SOUNDSTAR® 3D DIAGNOSTIC ULTRASOUND CATHETER CATHETER, ULTRASOUND, INTRAVASCULAR OBJ BIOSENSE WEBSTER, INC (IRWINDALE) M-5723-05 OEM_M-5723-05

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Death