BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARCTIC FRONT ADVANCE PRO¿ CARDIAC CRYOABLATION CATHETER

    MDR report key: 23437161 · Received October 31, 2025

    Report

    Report Number
    3002648230-2025-01055
    Event Type
    Injury
    Date Received
    October 31, 2025
    Date of Event
    September 24, 2025
    Report Date
    October 31, 2025
    Manufacturer
    MEDTRONIC CRYOCATH LP
    Product Code
    OAE
    PMA / PMN Number
    P100010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CONTINUATION OF D10: PRODUCT ID: 12FCC13 PRODUCT TYPE: SHEATH PRODUCT ID: 2ACH20 PRODUCT TYPE: MAPPING CATHETER PRODUCT ID: NON-MEDTRONIC PRODUCT TYPE: SHEATH PRODUCT ID: NON-MEDTRONIC PRODUCT TYPE: TRANSSEPTAL NEEDLE PRODUCT ID: NON-MEDTRONIC 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 REPORTED THAT DURING A CRYO ABLATION PROCEDURE, THE PATIENT WENT INTO CARDIAC ARREST POST ABLATION OF THE RIGHT LOWER PULMONARY VEIN (RLPV). A PERICARDIAL EFFUSION OCCURRED WHICH LEAD TO A CARDIAC TAMPONADE. A PERICARDIAL DRAIN WAS CARRIED OUT. THE PATIENT RECOVERED BUT DUE TO ANTI COAGULATION MEDICATION CONTINUED TO BLEED, OPEN CHEST SURGERY WAS REQUIRED AND CARRIED OUT. THE CASE WAS ABORTED THE PATIENT WAS NOT UNDER GENERAL ANESTHESIA. THE PATIENT WAS NOTED TO BE STABLE AFTER THE PROCEDURE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. IT WAS LATER REPORTED THAT THE AFTER THE RIGHT LOWER CRYOABLATION WAS FINISHED, THE PATIENT WAS UNRESPONSIVE AND EXPERIENCED A DROP IN BLOOD PRESSURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1562145 ARCTIC FRONT ADVANCE PRO¿ CARDIAC CRYOABLATION CATHETER CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FIBRILLATION OAE MEDTRONIC CRYOCATH LP AFAPRO28

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Life Threatening| R SEE H11...