BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEXCATH CROSS TRANSSEPTAL SOLUTION

    MDR report key: 23214274 · Received October 3, 2025

    Report

    Report Number
    3012120746-2025-00031
    Event Type
    Injury
    Date Received
    October 3, 2025
    Date of Event
    September 22, 2025
    Report Date
    December 11, 2025
    Manufacturer
    ACUTUS MEDICAL INC
    Product Code
    DYB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    UPDATED H6: PATIENT CODES (IME/ANNEX E). MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Additional Manufacturer Narrative · 0

    CONTINUATION OF D10: PRODUCT ID PSCC100 (0012783249); PRODUCT TYPE: 0609-CATHETER; PRODUCT ID 10FCC13 (0012804385); PRODUCT TYPE: 0629-FLEXCATH SHEATH; PRODUCT ID 990045 (8584496); PRODUCT TYPE: 0193-GUIDEWIRE; MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 30 MINUTES AFTER A COMPLETED PULSED FIELD ABLATION PROCEDURE, THE PATIENT'S BLOOD PRESSURE DROPPED. THE PATIENT HAD NO PAIN OR DISCOMFORT. A PERICARDIAL EFFUSION WAS IDENTIFIED AND PERICARDIOCENTESIS WAS PERFORMED, AND THE FLUID WAS DRAINED. IT WAS NOTED THAT THE PATIENT HAD PERICARDITIS. THE PATIENT'S HOSPITALIZATION WAS NOT EXTENDED AND THERE WAS NO OTHER INTERVENTIONS, OTHER THAN THE PERICARDIOCENTESIS. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1840387 FLEXCATH CROSS TRANSSEPTAL SOLUTION INTRODUCER, CATHETER DYB ACUTUS MEDICAL INC 900310 106878

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Life Threatening| R