BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEXCATH CROSS TRANSSEPTAL SOLUTION

    MDR report key: 23720571 · Received December 4, 2025

    Report

    Report Number
    3012120746-2025-00040
    Event Type
    Injury
    Date Received
    December 4, 2025
    Date of Event
    November 11, 2025
    Report Date
    January 8, 2026
    Manufacturer
    ACUTUS MEDICAL INC
    Product Code
    DYB
    UDI-DI
    00763000935504
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT EVENT SUMMARY: THE FLEXCATH CROSS WITH LOT 106667 WAS RETURNED AND ANALYZED. DURING VISUAL INSPECTION NO DAMAGE WAS OBSERVED WITH THE RETURNED DEVICE. THE USABLE LENGTH, CURVE ANGLE AND PLANARITY VERIFICATION WAS PERFORMED AND NO ANOMALIES WERE OBSERVED. IN CONCLUSION, THE DEVICE PASSED THE RETURNED PRODUCT INSPECTION AS PER SPECIFICATION. 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 PRODUCT TYPE: CATHETER. 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 LATER REPORTED THAT A PERICARDIOCENTESIS WAS PERFORMED BUT SURGERY WAS NOT REQUIRED. THE PHYSICIAN BELIEVES THAT THE PATIENT HAD A PREVIOUS 'MASS' WHICH IS THOUGHT TO HAVE CAUSED THE PERICARDIAL EFFUSION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A CARDIAC ABLATION PROCEDURE, A PATIENT DEVELOPED PERICARDIAL EFFUSION. THE PROCEDURE WAS ABORTED WHILE THE PATIENT WAS UNDER GENERAL ANESTHESIA. "FLUID DRAINAGE OR SURGERY" WAS PERFORMED. THE PATIENT WAS SENT TO THE INTENSIVE CARE UNIT. THE EVENT LED TO EXTENDED PATIENT HOSPITALIZATION, AND INJURY WAS REPORTED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    143834 FLEXCATH CROSS TRANSSEPTAL SOLUTION INTRODUCER, CATHETER DYB ACUTUS MEDICAL INC 900310 106667 00763000935504

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Hospitalization| R SEE H11.