BEUDAMED
    FDA Adverse Event Injury Summary report: N

    6VT-D

    MDR report key: 19668761 · Received July 3, 2024

    Report

    Report Number
    9610482-2024-00002
    Event Type
    Injury
    Date Received
    July 3, 2024
    Date of Event
    March 27, 2023
    Report Date
    July 3, 2024
    Manufacturer
    GE VINGMED ULTRASOUND AS
    Product Code
    ITX
    PMA / PMN Number
    K141093
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCKS A, D & E: NO INFORMATION WAS PROVIDED WITHIN THE COMPLAINT SOURCE DOCUMENT, MW5121146 (MDR REPORT KEY 1748844). GE HEALTHCARE INVESTIGATION HAS COMPLETED. DURING THE INVESTIGATION, THE COMPLAINT FILE WAS SEARCHED FOR A MATCHING REPORT FROM A CUSTOMER AND GE HEALTHCARE COULD NOT FIND A CUSTOMER COMPLAINT THAT MATCHED THIS MAUDE REPORT. THEREFORE, GE HEALTHCARE WAS UNABLE TO DETERMINE THE CUSTOMER AND THE EXACT TEE PROBE IN USE DURING THE ABLATION, NOR OBTAIN FURTHER INFORMATION ABOUT THE EVENT. BASED UPON THE DESCRIPTION WITHIN THE REPORT, IT WAS CONCLUDED THE 6VT-D PROBE IS MOST LIKELY THE TEE PROBE INVOLVED WITHIN THE ABLATION PROCEDURE. A PROBE MALFUNCTION COULD NOT BE CONFIRMED, AND THE MOST LIKELY CAUSE WAS ACCIDENTAL INJURY DURING INTUBATION/EXTUBATION OF THE 6VT-D PROBE AND/OR MANIPULATION OF THE PROBE. ESOPHAGEAL INJURY IS AN INHERENT WELL-DOCUMENTED RISK OF THE PROCEDURE. DESIGN AND LABELING MITIGATIONS FOR THE 6VT-D PROBE HAVE BEEN REDUCED AS FAR AS POSSIBLE, AND GE HEALTHCARE RISK BENEFIT ANALYSIS CONCLUDES THE 6VT-D PROBE BENEFIT OUTWEIGHS RESIDUAL RISKS. THEREFORE, NO FURTHER ACTION WILL BE TAKEN AT THIS TIME. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, GE HEALTHCARE WILL RE-EVALUATE THE COMPLAINT AND THE ADDITIONAL INFORMATION RECEIVED. LEGAL MANUFACTURER: (B)(4).

    Description of Event or Problem · 0

    GE HEALTHCARE BECAME AWARE OF MAUDE REPORT MW5121146 (MDR REPORT KEY 1748844) WITH THE FOLLOWING DESCRIPTION: POST PROCEDURE, AN ESOPHAGEAL TEAR WAS NOTED AND A TEMPORARY ESOPHAGEAL BYPASS WAS PLACED. FOLLOWING THE ABLATION PROCEDURE, THE PATIENT WOKE UP AND COMPLAINED OF SEVERE PAIN. A CT SCAN WAS PERFORMED WHICH REVEALED AN ESOPHAGEAL RUPTURE. IT IS NOT KNOWN AT THIS TIME WHETHER THE TEAR IS RELATED TO THE ABLATION OR THE TRANSESOPHAGEAL ULTRASOUND PROBE. CURRENTLY, THE PATIENT IS IN INTENSIVE CARE AND A TEMPORARY ESOPHAGEAL BYPASS HAS BEEN PLACED PENDING AN OPERATION IN THE NEXT FEW DAYS. (B)(6) 2023 - THE CARDIOLOGIST CONFIRMED THE HOLE IN THE ESOPHAGUS WAS DUE TO THE TRANSESOPHAGEAL ULTRASOUND PROBE (GE DEVICE).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    901460 6VT-D DIAGNOSTIC ULTRASOUND TRANSDUCER ITX GE VINGMED ULTRASOUND AS

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Prefer Not To Disclose Required Intervention