BEUDAMED
    FDA Adverse Event Death Summary report: N

    ION

    MDR report key: 19085269 · Received April 10, 2024

    Report

    Report Number
    2955842-2024-13041
    Event Type
    Death
    Date Received
    April 10, 2024
    Date of Event
    February 22, 2024
    Report Date
    March 20, 2024
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    EOQ
    UDI-DI
    00886874116234
    PMA / PMN Number
    K182188
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON THE CURRENT INFORMATION PROVIDED, THE CAUSE OF THE CARDIAC ARREST AND PATIENT OUTCOME CANNOT BE DETERMINED. SYSTEM LOGS WERE NOT AVAILABLE FOR REVIEW AT THIS TIME. A REVIEW OF THE EVENT WAS CONDUCTED BY AN INTUITIVE SURGICAL, INC. (ISI) MEDICAL SAFETY OFFICER AND THE FOLLOWING ADDITIONAL INFORMATION WAS PROVIDED: A 68-YEAR-OLD MALE UNDERWENT AN ION ENDOLUMINAL BIOPSY OF A 5.7CM LEFT UPPER LOBE LUNG MASS. ENDOBRONCHIAL ULTRASOUND (EBUS) STAGING WAS PERFORMED FIRST BEFORE THE ION BIOPSY. DURING THE ION BIOPSY BRADYCARDIA DEVELOPED COMPLICATED BY CARDIAC ARREST. ADVANCED CARDIA LIFE SUPPORT (ACLS) WAS INITIATED INCLUDING ATROPINE. THE PROCEDURE WAS ABORTED. ATTEMPTS AT OBTAINING FURTHER DATA HAVE BEEN UNSUCCESSFUL. THE PHYSICIAN ATTRIBUTED THE EVENT TO THE PATIENT¿S CARDIOVASCULAR HISTORY WITH NO DEVICE MALFUNCTION. BASED ON THE LIMITED AVAILABLE DATA THE EVENT WAS PROCEDURE-RELATED WITHOUT EVIDENCE OF MALFUNCTION OF THE ION SYSTEM, INSTRUMENTS, OR ACCESSORIES.

    Additional Manufacturer Narrative · 0

    SECTION B5 ADDITIONAL INFORMATION: THE PULMONOLOGIST REPORTED THAT AFTER THE CARDIAC ARREST EVENT THE PATIENT WAS REFERRED TO A CARDIOLOGIST WHO CHOSE NOT TO PERFORM CARDIAC CATHETERIZATION, BUT RATHER, RECOMMENDED ABLATION FOR THE TACHY-BRADY SYNDROME. THE PATIENT¿S FAMILY CHOSE NOT TO PURSUE FURTHER CARE, THE PATIENT WAS EXTUBATED AND AT LATER DEVELOPED ANOTHER CARDIAC EVENT AND CODED. THE PATIENT SUBSEQUENTLY EXPIRED ON AN UNSPECIFIED DATE. THE CAUSE OF DEATH WAS STATED AS CARDIAC ARRHYTHMIA. THE PHYSICIAN REPORTED THAT THE OUTCOME WAS NOT DEVICE-RELATED. DEVICE HISTORY RECORD (DHR) REVIEW-DHR REVIEW FOR THE DEVICE(S) INVOLVED WITH THE REPORTED EVENT FOUND NO NON-CONFORMANCES WERE IDENTIFIED TO BE RELATED TO THIS COMPLAINT. REVIEW OF THE ADDITIONAL BY AN INTUITIVE MEDICAL SAFETY OFFICER CONCLUDED THAT EBUS STAGING WAS PERFORMED FIRST PRIOR TO THE ION BIOPSY. DURING THE ION BIOPSY BRADYCARDIA DEVELOPED COMPLICATED BY CARDIAC ARREST. ACLS WAS INITIATED INCLUDING ATROPINE. THE PROCEDURE WAS ABORTED. THE PATIENT WAS DIAGNOSED WITH TACHY-BRADY SYNDROME FOR WHICH ABLATION WAS RECOMMENDED WHICH WAS DECLINED. THE PATIENT WAS TRANSITIONED TO COMFORT CARE MEASURES ONLY AND THE PATIENT DIED. THERE WAS NO MALFUNCTION OF THE ION SYSTEM, INSTRUMENTS OR ACCESSORIES. BASED ON THE AVAILABLE DATA THE EVENT WAS PROCEDURE-RELATED IN THE SETTING OF UNDERLYING CARDIAC DISEASE AND NOT DEVICE-RELATED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN ION ENDOLUMINAL LUNG BIOPSY PROCEDURE, AN EXPERIENCED CARDIAC ARREST. THE PATIENT HAD A SIGNIFICANT CARDIOVASCULAR HISTORY. ULTRASOUND BRONCHOSCOPY (EBUS) WAS USED TO PERFORM STAGING BEFORE THE ION PROCEDURE. THE TARGET NODULE WAS 5.7 CENTIMETERS (CM) IN SIZE AND LOCATED IN THE LEFT UPPER LOBE. DURING THE ION PROCEDURE, THE PATIENT EXPERIENCED BRADYCARDIA AND THE PROCEDURE WAS ABORTED. AN UNSPECIFIED TIME AFTER, THE PATIENT EXPERIENCED CARDIAC ARREST. ADVANCED CARDIAC LIFE SUPPORT (ACLS) WAS INITIATED, AND THE PATIENT RECEIVED ATROPINE. THE CARDIOLOGIST DETERMINED THAT THE CAUSE OF THE EVENT WAS TACHY-BRADY SYNDROME AGGRAVATED BY THE PATIENT¿S SIGNIFICANT CARDIOVASCULAR HISTORY. THE PHYSICIAN REPORTED THAT THE EVENT WAS NOT ION RELATED. THERE WAS NO DEVICE MALFUNCTION ASSOCIATED WITH THE EVENT.

    Description of Event or Problem · 0

    REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1407875 ION SYSTEM CART EOQ INTUITIVE SURGICAL, INC 380748-65 N/A 00886874116234

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Male Death ION ENDOLUMINAL SYSTEM