BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCTIC FRONT ADVANCE® CARDIAC CRYOABLATION CATHETER

    MDR report key: 23744335 · Received December 8, 2025

    Report

    Report Number
    2649622-2025-34136
    Event Type
    Malfunction
    Date Received
    December 8, 2025
    Date of Event
    December 4, 2025
    Report Date
    February 5, 2026
    Manufacturer
    MEDTRONIC PUERTO RICO VILLALBA
    Product Code
    OAE
    UDI-DI
    00763000367749
    PMA / PMN Number
    P100010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CONTINUATION OF D10: PRODUCT ID 203CX; PRODUCT TYPE: 0627-CABLES AND ACCESSORIES; PRODUCT ID 2035U; PRODUCT TYPE: 0627-CABLES AND ACCESSORIES. 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. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Additional Manufacturer Narrative · 0

    PRODUCT EVENT SUMMARY: THE DATA FILES WERE RETURNED AND ANALYZED. THE PATIENT FILE RECEIVED AND RECORDED ON THE REPORTED DATE OF THE EVENT. THE PATIENT FILE SHOWED 2 APPLICATIONS WERE PERFORMED USING A CATHETER IDENTIFIED AS 2AF283 BALLOON CATHETER OF LOT NUMBER 24835. THE PATIENT FILE #1 SHOWED 1 APPLICATION WAS PERFORMED USING A CATHETER IDENTIFIED AS 2AF283 BALLOON CATHETER OF LOT NUMBER 24108. THE PATIENT FILE #1 SHOWED SYSTEM NOTICE 50032 (THE SAFETY SYSTEM HAS DETECTED A COMPROMISED OUTER VACUUM) DURING INFLATION AT APPLICATION #1. NO SYSTEM NOTICE 50006 INDICATING THAT THE SAFETY SYSTEM DETECTED BLOOD IN THE CATHETER HANDLE, THE INJECTION WAS STOPPED AND THE VACUUM DISABLED WAS OBSERVED IN THE BIN FILES. THE FIVE RECEIVED IMAGE FILES SHOW A BALLOON CATHETER IN AFTER-USE CONDITION WITH A COAXIAL CABLE ATTACHED. BLOOD IS CLEARLY VISIBLE INSIDE THE BALLOON AND AT THE COAXIAL CABLE CONNECTION. ADDITIONALLY, ONE OF THE IMAGES DISPLAYS SYSTEM NOTICE 50006 TRIGGERED ON THE CONSOLE SCREEN. NO INFORMATION REGARDING THE CATHETER LOT/SERIAL NUMBER, CONSOLE ID, OR THE DATE OF THE PROCEDURE IS AVAILABLE IN THE RECEIVED IMAGES. IN CONCLUSION, THE REPORTED VISIBLE BLOOD WAS CONFIRMED VIA DATA ANALYSIS. THE PHYSICAL PRODUCT WAS NOT RETURNED FOR ANALYSIS. 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 CARDIAC ABLATION PROCEDURE USING THE CATHETER 2AF283 ARCTIC FRONT ADV OUS 28MM BALLOON CATHETER, APPRO XIMATELY 12 SECONDS AFTER BALLOON INFLATION A SYSTEM NOTICE WAS RECEIVED INDICATING THAT THE SAFETY SYSTEM DETECTED BLOOD IN THE CATHETER HANDLE, THE INJECTION WAS STOPPED AND THE VACUUM DISABLED. BLOOD WAS OBSERVED AT THE END OF THE COAXIAL UMBILICAL CABLE CONNECTED TO THE BALLOON HANDLE, PROMPTING IMMEDIATE CESSATION OF CRYOTHERAPY. UPON REMOVAL OF THE BALLOON, A LARGE AMOUNT OF BLOOD WAS FOUND INSIDE THE BALLOON. THE BALLOON CATHETER, COAXIAL UMBILICAL CABLE, AND ELECTRICAL UMBILICAL CABLE WERE REPLACED. THE CASE WAS COMPLETED WITH CRYO. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    142645 ARCTIC FRONT ADVANCE® CARDIAC CRYOABLATION CATHETER CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FIBRILLATION OAE MEDTRONIC PUERTO RICO VILLALBA 2AF283 24108 00763000367749

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Female SEE H11...