BEUDAMED
    FDA Adverse Event Death Summary report: N

    NOGA-STAR¿ CARDIOLOGY CATHETER

    MDR report key: 7463326 · Received April 25, 2018

    Report

    Report Number
    2029046-2018-01424
    Event Type
    Death
    Date Received
    April 25, 2018
    Date of Event
    February 26, 2018
    Report Date
    March 28, 2018
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    DRF
    UDI-DI
    10846835002058
    PMA / PMN Number
    K954390
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED ON MAY 18, 2018 PROVIDING THE DATE OF DEATH. THEREFORE. DATE OF DEATH. MANUFACTURER'S REFERENCE NUMBER: (B)(4).

    Additional Manufacturer Narrative · 1

    NO DEVICE WAS RECEIVED FOR ANALYSIS AT THE TIME OF SUBMISSION OF THE INITIAL 3500A. SINCE THE PRODUCT WAS NOT RETURNED FOR ANALYSIS, NO PRODUCT FAILURE ANALYSIS CAN BE CONDUCTED AND NO DETERMINATION OF POSSIBLE CONTRIBUTING FACTORS COULD BE MADE. DEVICE HISTORY RECORD (DHR) REVIEW CANNOT BE CONDUCTED BECAUSE NO LOT NUMBER WAS PROVIDED BY THE CUSTOMER. THE DATE OF DEATH HAS NOT BEEN PROVIDED; CLARIFICATION ON THE FACILITY HAS BEEN REQUESTED. HOWEVER, NO FURTHER INFORMATION HAS BEEN MADE AVAILABLE. IF ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. CONCOMITANT PRODUCT: MYOSTAR: US CATALOG #: 121120S, LOT #: UNKNOWN. NOGA XP 3D CARDIAC NAVIGATION SYSTEM: US CATALOG #: UNKNOWN, SERIAL #: UNKNOWN. (B)(4).

    Description of Event or Problem · 1

    ORIGINALLY, IT WAS REPORTED THAT THE BIOSENSE WEBSTER, INC. DEVICE USED IN THE PROCEDURE WAS THE MYOSTAR. THIS DEVICE HAS NOT BEEN APPROVED BY THE US FDA AND IS NOT MARKETED IN THE U.S, THEREFORE, THIS EVENT WAS ASSESSED AS NOT MDR REPORTABLE UNDER THIS DEVICE. HOWEVER, ON MARCH 28, 2018 ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THE NOGA-STAR¿ CARDIOLOGY CATHETER WAS ALSO USED IN THE PROCEDURE. THEREFORE, THIS EVENT IS BEING ASSESSED AS MDR REPORTABLE UNDER THE NOGA-STAR¿ CARDIOLOGY CATHETER WITH THE AWARENESS DATE OF MARCH 28, 2018. IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT A NOGA XP-GUIDED INTRA-MYOCARDIAL STEM CELL INJECTION PROCEDURE FOR HEART FAILURE WITH A MYOSTAR INJECTION CATHETER AND A NOGA-STAR¿ CARDIOLOGY CATHETER AND SUFFERED A CARDIAC TAMPONADE (REQUIRING SURGICAL INTERVENTION) AND DEATH. PATIENT WAS PREVIOUSLY ASSIGNED TO THE PLACEBO GROUP OF THE RELATED CLINICAL TRIAL. AFTER OBSERVING THE SIGNIFICANT THERAPEUTIC BENEFITS RECEIVED BY THE TREATMENT GROUP, THE PHYSICIAN CONTACTED THE PATIENT AND OFFERED COMPASSIONATE TREATMENT. PRE-PROCEDURE, ECHOCARDIOGRAPHIC IMAGES WERE OF POOR QUALITY, BUT COMPUTED TOMOGRAPHY (CT) CONFIRMED THE ABSENCE OF A PERICARDIAL EFFUSION. MAPPING AND INJECTION PROCEDURE WAS COMPLETED WITHOUT INCIDENT. ARTERIAL ACCESS SITE WAS CLOSED. POST-PROCEDURE ECHOCARDIOGRAPHY SUGGESTED A SMALL HEMODYNAMICALLY STABLE PERICARDIAL EFFUSION. SUBSEQUENTLY, THE PATIENT BECAME SIGNIFICANTLY HYPOTENSIVE AND A GROWING EFFUSION WAS CONFIRMED VIA ECHOCARDIOGRAPHY. PERICARDIOCENTESIS YIELDED 400 ML OF BLOOD. PERICARDIAL DRAIN PLACEMENT WAS UNSUCCESSFUL. PATIENT WAS TRANSFERRED TO THE OPERATING ROOM WHERE 1000 ML OF FLUID WAS DRAINED. PATIENT WAS TRANSFERRED TO THE INTENSIVE CARE UNIT (ICU) WHILE INTUBATED AND ON INOTROPIC SUPPORT. ON POST-PROCEDURE DAY 1, THE PATIENT WAS NOTED TO BE WEAK. APPROXIMATELY 2 WEEKS POST-PROCEDURE, THE PATIENT EXPIRED. ACCORDING TO THE PATHOLOGIST, THERE WAS NO VISIBLE EVIDENCE OF TRAUMATIC TISSUE DAMAGE TO INDICATE THAT A CATHETER OR NEEDLE PERFORATED THE TISSUE. AUTOPSY REVEALED THAT THE PATIENT SUFFERED MULTI-SYSTEM ORGAN FAILURE (MSOF), PERICARDIAL EFFUSION, ISCHEMIC HEART FAILURE, AND KIDNEY FAILURE. IT WAS NOTED THAT MANY PATIENTS INVOLVED IN THE NOGA XP-GUIDED INTRA-MYOCARDIAL STEM CELL INJECTION PROCEDURE FOR HEART FAILURE ARE IN THE CATEGORY OF ¿NO OPTION PATIENTS.¿ THESE PATIENTS ARE NO LONGER ELIGIBLE FOR BYPASS SURGERY, PTCA, STENTS, OR OTHER TYPES OF REVASCULARIZATION. ALTHOUGH IT WAS NOTED THAT THE EFFUSION WAS POTENTIALLY RELATED TO CATHETER MANIPULATION, THERE WAS NO SPECIFIC POINT DURING THE CASE WHERE THE PHYSICIAN SUSPECTED THE INJURY TO HAVE OCCURRED. PATIENT FACTORS THAT MAY HAVE CONTRIBUTED TO THE ADVERSE EVENT INCLUDE MULTI-SYSTEM ORGAN FAILURE (MSOF), PERICARDIAL EFFUSION, ISCHEMIC HEART FAILURE, AND KIDNEY FAILURE. PHYSICIAN¿S OPINION REGARDING THE CAUSE OF THE ADVERSE EVENT IS THAT IT WAS PROCEDURE-RELATED. THERE WERE NO ISSUES, ERRORS, OR MALFUNCTIONS ASSOCIATED WITH ANY BIOSENSE WEBSTER, INC. CATHETERS OR EQUIPMENT DURING THE PROCEDURE. NO TRANSSEPTAL PUNCTURE WAS PERFORMED. AN 8 FRENCH INTRODUCER SHEATH WAS USED. PATIENT RECEIVED ANTICOAGULANT DURING THE PROCEDURE WITH ACTIVATED CLOTTING TIME (ACT) MAINTAINED AT APPROXIMATELY 250 SECONDS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    300698 NOGA-STAR¿ CARDIOLOGY CATHETER CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING DRF BIOSENSE WEBSTER INC UNKNOWN 10846835002058

    Patients

    Seq Age Sex Outcome Treatment
    1 Death| H| R