BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARCTIC FRONT ADVANCE PRO¿ CARDIAC CRYOABLATION CATHETER

    MDR report key: 23768599 · Received December 10, 2025

    Report

    Report Number
    2649622-2025-34436
    Event Type
    Injury
    Date Received
    December 10, 2025
    Date of Event
    November 24, 2025
    Report Date
    February 19, 2026
    Manufacturer
    MEDTRONIC PUERTO RICO VILLALBA
    Product Code
    OAE
    UDI-DI
    00763000524197
    PMA / PMN Number
    P100010
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT EVENT SUMMARY: THE DATA FILES WERE RETURNED AND ANALYZED. 1 PATIENT FILE WAS RECEIVED AND RECORDED ON THE REPORTED DATE OF THE EVENT. THE PATIENT FILE SHOWED 7 APPLICATIONS WERE PERFORMED USING THE RETURNED CATHETER. THE PATIENT FILE SHOWED 4 APPLICATIONS WERE PERFORMED USING A NON-RETURNED CATHETER. PATIENT FILE DID NOT SHOW ANY SYSTEM NOTICE ON THE REPORTED DATE OF THE EVENT. THE RECEIVED FAILURE FILE CONTAINED FAILURE RECORDS FOR THE DATE OF THE EVENT. THE FAILURE FILE SHOWED SYSTEM NOTICE 50005 (THE SAFETY SYSTEM HAS DETECTED FLUID IN THE CATHETER AND STOPPED THE INJECTION) ON THE REPORTED DATE OF THE EVENT. THE FAILURE FILE SHOWED SYSTEM NOTICE 50006 (THE SAFETY SYSTEM HAS DETECTED BLOOD IN THE CATHETER HANDLE STOPPED THE INJECTION AND DISABLED THE VACUUM) ON THE REPORTED DATE OF THE EVENT. IN CONCLUSION, THE REPORTED SYSTEM NOTICE WAS CONFIRMED THROUGH DATA ANALYSIS. THE PHYSICAL PRODUCT IS YET TO BE ANALYZED. 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

    PRODUCT EVENT SUMMARY: THE AFAPRO28 BALLOON CATHETER WITH LOT NUMBER 26988 WAS RETURNED AND ANALYZED. EXTERNAL VISUAL INSPECTION OF THE BALLOON SEGMENT SHOWED BLOOD/FLUID INSIDE THE BALLOON. THE CATHETER SMART CHIP DATA WAS DOWNLOADED AND REVIEWED. DATA INDICATED THE CATHETER WAS USED FOR 7 APPLICATIONS ON THE REPORTED EVENT DATE. DURING FUNCTIONAL TESTING, THE CONSOLE TERMINATED THE APPLICATION AND TRIGGERED SYSTEM NOTICE 50005 "THE SAFETY SYSTEM DETECTED FLUID IN THE CATHETER AND STOPPED THE INJECTION." PRESSURE TESTING AND INSPECTION WAS PERFORMED ON THE SUB-COMPONENTS OF THE BALLOON, HANDLE, AND SHAFT SEGMENTS. DURING INSPECTION OF THE SHAFT SEGMENT, A SHAFT BREACH WAS OBSERVED 19.5 INCHES FROM THE CATHETER TIP. DURING INSPECTION OF THE HANDLE SEGMENT, BLOOD/LIQUID WAS OBSERVED INSIDE THE HANDLE. IN CONCLUSION, THE REPORTED VISIBLE BLOOD WAS CONFIRMED THROUGH ANALYSIS. THE BALLOON CATHETER FAILED THE RETURNED PRODUCT INSPECTION DUE TO THE BREACH OBSERVED ON THE CATHETER SHAFT. 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, A SYSTEM NOTICE WAS RECEIVED INDICATING THAT THE SAFETY SYSTEM DETECTED BLOOD IN THE CATHETER HANDLE, THE INJECTION WAS STOPPED AND THE VACUUM DISABLED. THE CATHETER WAS IMMEDIATELY DISCONNECTED FROM THE CONSOLE AND BLOOD WAS VISIBLE IN THE CATHETER. THE PATIENT HAD AN ASYSTOLE DIRECTLY AFTER THE SYSTEM NOTICE BUT QUICKLY RECOVERED WITH CARDIOPULMONARY RESUSCITATION AND MEDICATION ADMINISTERED. THE CASE WAS COMPLETED WITH CRYO. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2877327 ARCTIC FRONT ADVANCE PRO¿ CARDIAC CRYOABLATION CATHETER CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FIBRILLATION OAE MEDTRONIC PUERTO RICO VILLALBA AFAPRO28 26988 00763000524197

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Life Threatening