BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEXCATH CROSS TRANSSEPTAL SOLUTION

    MDR report key: 23243544 · Received October 8, 2025

    Report

    Report Number
    3012120746-2025-00032
    Event Type
    Injury
    Date Received
    October 8, 2025
    Date of Event
    September 10, 2025
    Report Date
    November 13, 2025
    Manufacturer
    ACUTUS MEDICAL INC
    Product Code
    DYB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CONTINUATION OF D10: PRODUCT ID: PSCC100 PRODUCT TYPE: CATHETER PRODUCT ID: 10FCC13 PRODUCT TYPE: SHEATH 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: NON-MEDTRONIC PRODUCT, PRODUCT TYPE: GUIDEWIRE PRODUCT ID: NON-MEDTRONIC PRODUCT, PRODUCT TYPE: PULSE COUNTER, PRODUCT ID: NON-MEDTRONIC PRODUCT, PRODUCT TYPE: ELECTROPHYSIOLOGY (EP) CATHETER PRODUCT ID: NON-MEDTRONIC PRODUCT, PRODUCT TYPE: ICE CATHETER PRODUCT ID: NON-MEDTRONIC PRODUCT, PRODUCT TYPE: SHORT SHEATHS PRODUCT ID: NON-MEDTRONIC PRODUCT, PRODUCT TYPE: SHORT SHEATHS PRODUCT ID: NON-MEDTRONIC PRODUCT, PRODUCT TYPE: SHORT SHEATHS PRODUCT ID: NON-MEDTRONIC PRODUCT, PRODUCT TYPE: SHORT SHEATHS. 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 DURING A PULSED FIELD ABLATION PROCEDURE, CARDIAC TAMPONADE OCCURRED. HYPOTENSION WAS OBSERVED AT THE COMPLETION OF PULMONARY VEIN ISOLATION (PVI). PERICARDIAL EFFUSION WAS CONFIRMED VIA IMAGING. PERICARDIOCENTESIS WAS PERFORMED, LEADING TO A RECOVERY OF THE BLOOD PRESSURE AND OTHER PARAMETERS. THE PATIENT UNDERWENT EXTENDED HOSPITALIZATION. THE PATIENT'S OUTCOME IS CURRENTLY UNKNOWN. THE CASE WAS COMPLETED WITH PULSED FIELD ABLATION. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 0

    IT WAS LATER REPORTED THAT THE PATIENT IS IN RECOVERY AND WAS SAFETY DISCHARGED AFTER INTENSIVE CARE UNIT (ICU) HOSPITALIZATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2610992 FLEXCATH CROSS TRANSSEPTAL SOLUTION INTRODUCER, CATHETER DYB ACUTUS MEDICAL INC 900310 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Life Threatening| H| R SEE H11