ARCTIC FRONT ADVANCE® CARDIAC CRYOABLATION CATHETER
Report
- Report Number
- 2649622-2025-31181
- Event Type
- Malfunction
- Date Received
- November 6, 2025
- Date of Event
- October 27, 2025
- Report Date
- January 15, 2026
- Manufacturer
- MEDTRONIC PUERTO RICO VILLALBA
- Product Code
- OAE
- UDI-DI
- 00763000707804
- PMA / PMN Number
- P100010
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SW
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
CONTINUATION OF D10: PRODUCT ID: NITRON; PRODUCT TYPE: CONSOLE; PRODUCT ID: 2AF283; PRODUCT TYPE: BALLOON CATHETER; PRODUCT ID: 2AF283; PRODUCT TYPE: BALLOON 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.
PRODUCT EVENT SUMMARY: DATA FILES WERE RETURNED AND ANALYZED. THE CASE FILE WAS NOT AVAILABLE FOR ANALYSIS ON THE REPORTED EVENT DATE. IN THE FAULT FILE, THE FOLLOWING FAULT MESSAGE(S) WAS(WERE) FOUND ON THE REPORTED EVENT DATE. THE SYSTEM NOTICE N-004 "THE SYSTEM HAS DETECTED BLOOD IN THE CATHETER HANDLE AND STOPPED THE VACUUM." WAS CONFIRMED DURING THE FAULT PASSIVE STATE. THE SYSTEM NOTICE N-006 "THE SYSTEM HAS DETECTED BLOOD IN THE CATHETER" WAS CONFIRMED DURING THE READY STATE. THE SYSTEM NOTICE N-027 "THE SYSTEM HAS DETECTED AN UNEXPECTED TEMPERATURE DURING SYSTEM FLUSH." WAS CONFIRMED DURING THE FAULT EVACUATE STATE. IN CONCLUSION, THE REPORTED ISSUE WAS OBSERVED THROUGH DATA ANALYSIS. THE PHYSICAL PRODUCT, 2AF283 ARCTIC FRONT ADVANCE IS PENDING RETURN 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.
PRODUCT EVENT SUMMARY: THE 2AF283 ARCTIC FRONT ADVANCE CATHETER WITH LOT 26667 WAS RETURNED AND ANALYZED. EXTERNAL VISUAL INSPECTION OF THE BALLOON SEGMENT SHOWED BLOOD/FLUID INSIDE THE BALLOON. EXTERNAL VISUAL INSPECTION OF THE ELECTRICAL CONNECTOR SHOWED A BROKEN ELECTRICAL CONNECTOR INSULATOR BUTTON. DUE TO THIS ISSUE, CATHETER COULD NOT PROPERLY LOCK/CONNECT WITH THE ELECTRICAL UMBILICAL CABLE. THE CATHETER SMART CHIP DATA WAS DOWNLOADED AND REVIEWED. DATA INDICATED THE CATHETER WAS USED FOR ONE APPLICATION ON THE REPORTED EVENT DATE. DURING FUNCTIONAL TESTING, THE CONSOLE TERMINATED THE APPLICATION AND TRIGGERED AN N004 SYSTEM NOTICE (AN ERROR MESSAGE WAS RECEIVED STATING THAT THE SYSTEM DETECTED BLOOD IN THE CATHETER HANDLE AND STOPPED THE VACUUM). DURING PRESSURE TESTING OF THE BALLOON SEGMENT, AN OUTER BALLOON BREACH WAS OBSERVED. DISSECTION OF THE BALLOON SEGMENT IDENTIFIED AN OUTER BALLOON BREACH (PINHOLE TYPE). IN CONCLUSION, THE REPORTED "VISIBLE BLOOD" ISSUE WAS OBSERVED DURING TESTING. THE CATHETER FAILED THE RETURNED PRODUCT INSPECTION DUE TO A PIN-SIZED HOLE ON THE SURFACE OF THE OUTER BALLOON AND A BROKEN ELECTRICAL CONNECTOR INSULATOR BUTTON. 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.
IT WAS REPORTED THAT DURING A CRYO ABLATION PROCEDURE, AN ERROR MESSAGE WAS RECEIVED STATING THAT THE SYSTEM DETECTED INSUFFICIENT FLOW AT THE START OF THE APPLICATION INDICATING THE TREATMENT UNDERFLOW WAS FAST, AN ERROR MESSAGE WAS RECEIVED STATING THAT THE SYSTEM DETECTED BLOOD IN THE CATHETER HANDLE AND STOPPED THE VACUUM AND AN ERROR MESSAGE WAS RECEIVED STATING THAT THE SYSTEM DETECTED BLOOD IN THE CATHETER INDICATING THERE WAS BLOOD DETECTED AT THE PATIENT BOARD (CATHETER SHAFT IMPEDANCE WIRE BLOOD DETECTION). THE CONSOLE WAS SWITCHED OUT AND ANOTHER SYSTEM NOTICE WAS RECEIVED. THE BALLOON CATHETER, SHEATH AND AUTO CONNECTION BOX WERE REPLACED AND THE COAXIAL UMBILICAL CABLE WAS REPLACED TWICE WITHOUT RESOLVE. THE CATHETER WAS REPLACED A FOURTH TIME TO RESOLVE THE ISSUE. IT WAS NOTED THAT THE THREE BALLOON CATHETERS WERE NOTED TO HAVE VISIBLE BLOOD. THE CASE WAS COMPLETED WITH CRYO. THE CONSOLE WAS INSPECTED AND NO VISIBLE BLOOD WAS FOUND IN THE CONSOLE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2636916 | ARCTIC FRONT ADVANCE® CARDIAC CRYOABLATION CATHETER | CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FIBRILLATION | OAE | MEDTRONIC PUERTO RICO VILLALBA | 2AF283 | 26667 | 00763000707804 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | SEEH11 |