AFFERA
Report
- Report Number
- 9612164-2026-00656
- Event Type
- Malfunction
- Date Received
- February 5, 2026
- Date of Event
- January 27, 2026
- Report Date
- May 6, 2026
- Manufacturer
- MEDTRONIC IRELAND
- Product Code
- QZI
- UDI-DI
- 00763000973513
- PMA / PMN Number
- P240013
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
PRODUCT EVENT SUMMARY: THE DATA FILES WERE RETURNED AND ANALYZED. MULTIPLE MESSAGES WERE RECEIVED. DATE DEVICE TYPE MESSAGE 2026-01-27 15:40:28 CIU WARNING MAGNETIC TRACKING INITIALIZING' 2026-01-27 15:40:29 RFG WARNING RETURN 2 CQM IMPEDANCE 40% INCREASE' 2026-01-27 15:40:30 WARNING LOCATION REFERENCE NOT CALIBRATED' 2026-01-27 15:40:30 CRITICAL ABL CATHETER NOT CONNECTED TO HEXAMAP\XE2\X84\XA2' 2026-01-27 15:40:30 RFG WARNING RETURN 1 CQM IMPEDANCE 40% INCREASE' 2026-01-27 15:40:56 CRITICAL DATA SAVE FAULT' 2026-01-27 15:41:23 CRITICAL NO ANTERIOR PATCH DETECTED' 2026-01-27 15:43:05 CRITICAL NO ANTERIOR PATCH DETECTED' 2026-01-27 15:43:08 INFORMATION CIU IS OFFLINE' 2026-01-27 15:43:08 INFORMATION GENERATOR IS OFFLINE' 2026-01-27 16:04:36 CRITICAL DATA SAVE FAULT' 2026-01-27 16:08:11 CRITICAL DATA SAVE FAULT' 2026-01-27 14:14:54 CIU WARNING MAGNETIC TRACKING INITIALIZING' 2026-01-27 14:15:03 WARNING LOCATION REFERENCE NOT CALIBRATED' 2026-01-27 14:25:37 CIU INFORMATION ABL CATHETER LOADING' 2026-01-27 14:25:38 RFG CRITICAL CATHETER TEMPERATURE SENSOR FAULT' 2026-01-27 14:25:40 RFG CRITICAL CATHETER TEMPERATURE SENSOR FAULT' 2026-01-27 14:25:40 RFG WARNING TEMPERATURE ACQUISITION CIRCUIT FAILURE' 2026-01-27 14:25:40 RFG INFORMATION TEMPERATURE ACQUISITION CIRCUIT DEGRADATION' 2026-01-27 14:25:41 RFG CRITICAL CATHETER TEMPERATURE SENSOR FAULT' 2026-01-27 14:25:41 RFG CRITICAL CATHETER TEMPERATURE SENSOR FAULT' 2026-01-27 14:26:28 RFG CRITICAL PUMP PURGE ACTIVE' 2026-01-27 14:26:29 RFG CRITICAL PUMP PURGE ACTIVE' 2026-01-27 14:26:29 RFG CRITICAL PUMP STOPPED: BUBBLE DETECTED' 2026-01-27 14:26:48 RFG CRITICAL CATHETER PREP. SEQUENCE RUNNING' 2026-01-27 14:28:26 RFG CRITICAL PUMP STOPPED' 2026-01-27 14:28:28 RFG CRITICAL PUMP PURGE ACTIVE' 2026-01-27 14:28:36 RFG CRITICAL CATHETER PREP. SEQUENCE RUNNING' 2026-01-27 14:29:06 RFG CRITICAL PUMP PURGE ACTIVE' 2026-01-27 15:13:46 RFG INFORMATION PATIENT TEMPERATURE TOO LOW' 2026-01-27 15:13:47 RFG INFORMATION PATIENT TEMPERATURE TOO LOW' 2026-01-27 15:15:06 RFG WARNING IMPEDANCE CHANGE RATE TOO HIGH' 2026-01-27 15:15:41 RFG INFORMATION PATIENT TEMPERATURE TOO LOW' 2026-01-27 15:16:01 RFG WARNING IMPEDANCE CHANGE RATE TOO HIGH' 2026-01-27 15:18:06 RFG INFORMATION PATIENT TEMPERATURE TOO LOW' 2026-01-27 15:22:27 RFG WARNING INTERNAL MONITORING OUT OF RANGE' 2026-01-27 15:32:55 CRITICAL DATA SAVE FAULT' 2026-01-27 15:32:56 CIU CRITICAL PACING COMMUNICATIONS FAILURE' 2026-01-27 15:32:59 RFG CRITICAL PUMP STOPPED' 2026-01-27 15:33:08 RFG CRITICAL PUMP HOUSING OPEN' 2026-01-27 15:33:24 CIU WARNING MAGNETIC TRACKING INITIALIZING' 2026-01-27 15:33:26 WARNING VIDEO NOT SAVED' 2026-01-27 15:37:19 RFG WARNING ABL CATHETER NOT CONNECTED' 2026-01-27 15:37:19 CIU WARNING ABL CATHETER NOT CONNECTED TO HEXAMAP\XE2\X84\XA2' 2026-01-27 15:37:19 RFG CRITICAL CATHETER TEMPERATURE SENSOR FAULT' 2026-01-27 15:40:26 RFG CRITICAL RETURN 4 CONTACT QUALITY POOR' 2026-01-27 15:40:26 RFG WARNING RETURN 4 CQM IMPEDANCE 40% INCREASE' 2026-01-27 15:40:28 RFG WARNING RETURN 3 CQM IMPEDANCE 40% INCREASE' 2026-01-27 15:40:28 CIU WARNING MAGNETIC TRACKING INITIALIZING' 2026-01-27 15:40:29 RFG WARNING RETURN 2 CQM IMPEDANCE 40% INCREASE' 2026-01-27 15:40:30 WARNING LOCATION REFERENCE NOT CALIBRATED' 2026-01-27 15:40:30 CRITICAL ABL CATHETER NOT CONNECTED TO HEXAMAP\XE2\X84\XA2' 2026-01-27 15:40:30 RFG WARNING RETURN 1 CQM IMPEDANCE 40% INCREASE' 2026-01-27 15:40:56 CRITICAL DATA SAVE FAULT' 2026-01-27 15:41:23 CRITICAL NO ANTERIOR PATCH DETECTED' 2026-01-27 15:43:05 CRITICAL NO ANTERIOR PATCH DETECTED' 2026-01-27 15:43:08 INFORMATION CIU IS OFFLINE' 2026-01-27 15:43:08 INFORMATION GENERATOR IS OFFLINE' 2026-01-27 16:04:36 CRITICAL DATA SAVE FAULT' 2026-01-27 16:08:11 CRITICAL DATA SAVE FAULT' IN CONCLUSION, THE REPORTED "STEAM POP" CANNOT BE OBSERVED THROUGH FILE 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 AFR-00001 SPHERE 9 CATHETER WITH LOT 0013126440 AND DATA FILES WERE RETURNED AND ANALYZED. ONE IMAGE FILE WAS RETURNED FROM THE FIELD. THE IMAGE FILE SHOWED RADIOFREQUENCY (RF) LESION #51 TAGGED AS STEAM POP. IT CAN ALSO BE OBSERVED THAT THERE WAS A SIGNIFICANT RISE IN TEMPERATURE GRAPH WITH A DROP IN CURRENT LEVEL. DURING EXTERNAL VISUAL INSPECTION, THE CATHETER WAS FOUND TO BE INTACT, AND NO DEFECTS WERE OBSERVED. THE CIRRIS TESTER WAS USED ON THE CATHETER FOR SHORTS AND MAPPING TESTS, AND THE TESTS PASSED SUCCESSFULLY. THE CATHETER WAS FUNCTIONALLY TESTED USING TEST CAPITAL EQUIPMENT. RF AND PULSE FIELD ABLATIONS WERE COMPLETED SUCCESSFULLY WITH THE CATHETER. A NEW MAP WAS STARTED, AND THE CATHETER WAS ABLE TO MAP APPROPRIATELY. THE USON TESTER WAS USED ON THE CATHETER TO CHECK FOR LEAK AND FLOW. THE OCCLUSION TEST FAILED BUT THE LEAK TEST PASSED. IN CONCLUSION, THE REPORTED STEAM POP IS PLAUSIBLE THROUGH DATA ANALYSIS BUT WAS NOT OBSERVED DURING TESTING. THE CATHETER PASSED THE RETURNED PRODUCT INSPECTION. 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.
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 AFR-00001 SPHERE 9 CATHETER WITH LOT 0013126440 AND DATA FILES WERE RETURNED AND ANALYZED. ONE IMAGE FILE WAS RETURNED FROM THE FIELD. THE IMAGE FILE SHOWED RADIOFREQUENCY (RF) LESION #51 TAGGED AS STEAM POP. IT CAN ALSO BE OBSERVED THAT THERE WAS A SIGNIFICANT RISE IN TEMPERATURE GRAPH WITH A DROP IN CURRENT LEVEL. DURING EXTERNAL VISUAL INSPECTION, THE CATHETER WAS FOUND TO BE INTACT, AND NO DEFECTS WERE OBSERVED. THE CIRRIS TESTER WAS USED ON THE CATHETER FOR SHORTS AND MAPPING TESTS, AND THE TESTS PASSED SUCCESSFULLY. THE CATHETER WAS FUNCTIONALLY TESTED USING TEST CAPITAL EQUIPMENT. RF AND PULSE FIELD ABLATIONS WERE COMPLETED SUCCESSFULLY WITH THE CATHETER. A NEW MAP WAS STARTED, AND THE CATHETER WAS ABLE TO MAP APPROPRIATELY. THE USON TESTER WAS USED ON THE CATHETER TO CHECK FOR LEAK AND FLOW. THE OCCLUSION TEST AND THE LEAK TEST PASSED. IN CONCLUSION, THE REPORTED STEAM POP IS PLAUSIBLE THROUGH DATA ANALYSIS BUT WAS NOT OBSERVED DURING TESTING. THE CATHETER PASSED THE RETURNED PRODUCT INSPECTION. 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 REPEAT ATRIAL FIBRILLATION PROCEDURE, A STEAM POP OCCURRED WHILE USING THE SPHERE 9 ABLATION CATHETER. THE PROCEDURE INVOLVED POSTERIOR WALL ISOLATION WITH PULSED FIELD ABLATION (PFA), FOLLOWED BY A SWITCH TO RADIOFREQUENCY (RF) ENERGY TO CREATE AN ANTERIOR LINE BETWEEN THE MITRAL VALVE AND THE RIGHT SUPERIOR PULMONARY VEIN. THE GENERATOR STOPPED DURING LESION #50 FOR AN UNSPECIFIED REASON, AND A STEAM POP WAS NOTED DURING LESION #51. A TRANSTHORACIC ECHOCARDIOGRAM WAS PERFORMED AFTER THE STEAM POP, AND NO INJURY WAS DETECTED. THE PROCEDURE WAS CONTINUED AND COMPLETED USING PULSED FIELD ABLATION ENERGY WITHOUT FURTHER ISSUES. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 224025 | AFFERA | PERCUTANEOUS CARDIAC ABLATION CATHETER FOR TREATMENT OF ATRIAL FIBRILLATION WITH | QZI | MEDTRONIC IRELAND | AFR-00001 | 0013126440 | 00763000973513 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |