AFFERA
Report
- Report Number
- 3012520654-2025-00030
- Event Type
- Injury
- Date Received
- April 7, 2025
- Date of Event
- March 17, 2025
- Report Date
- July 10, 2025
- Manufacturer
- MEDTRONIC, INC.
- Product Code
- QZI
- PMA / PMN Number
- P240013
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
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. LOG FILES RETURNED FROM THE FIELD SHOWED THE FOLLOWING TIME STAMPS/ERRORS: NOTIFICATIONS DATE DEVICE TYPE MESSAGE (B)(6) 2025 09:54:18 WARNING LOCATION REFERENCE NOT CALIBRATED' (B)(6) 2025 09:54:21 CRITICAL NO LOCATION PATCHES DETECTED' (B)(6) 2025 10:06:19 RFG CRITICAL PUMP STOPPED' (B)(6) 2025 10:10:42 RFG CRITICAL NO PUMP FLOW' (B)(6) 2025 10:11:10 RFG CRITICAL CATHETER PREP. SEQUENCE RUNNING' (B)(6) 2025 10:11:41 RFG CRITICAL PUMP PURGE ACTIVE' (B)(6) 2025 10:13:54 RFG WARNING INTERNAL MONITORING OUT OF RANGE' (B)(6) 2025 10:29:42 RFG WARNING INTERNAL MONITORING OUT OF RANGE' (B)(6) 2025 10:41:50 RFG CRITICAL RETURNS 1,2,3,4 CONTACT QUALITY POOR' (B)(6) 2025 10:41:50 RFG WARNING RETURN 1 CQM IMPEDANCE 40% INCREASE' (B)(6) 2025 10:41:50 RFG WARNING RETURN 2 CQM IMPEDANCE 40% INCREASE' (B)(6) 2025 10:41:50 RFG WARNING RETURN 3 CQM IMPEDANCE 40% INCREASE' (B)(6) 2025 10:41:50 RFG WARNING RETURN 4 CQM IMPEDANCE 40% INCREASE' POSSIBLE CATHETER SERIAL NUMBERS: AA001264129303 NOTIFICATIONS DATE DEVICE TYPE MESSAGE (B)(6) 2025 07:33:46 CIU CRITICAL CATHETER CHIP READ FAILED' (B)(6) 2025 07:33:54 WARNING LOCATION REFERENCE NOT CALIBRATED' (B)(6) 2025 07:33:57 CRITICAL NO LOCATION PATCHES DETECTED' (B)(6) 2025 07:34:57 RFG CRITICAL REMOTE CONTROL IS IN USE BUT OFFLINE!' (B)(6) 2025 07:35:35 RFG CRITICAL GENERATOR UI NOT RESPONDING' (B)(6) 2025 07:35:54 RFG CRITICAL PUMP HOUSING OPEN' (B)(6) 2025 07:35:54 RFG CRITICAL PUMP STOPPED' (B)(6) 2025 08:26:32 RFG CRITICAL PUMP HARDWARE FAULT' (B)(6) 2025 08:40:35 CRITICAL NO LOCATION PATCHES DETECTED' (B)(6) 2025 08:40:46 CRITICAL NO LOCATION PATCHES DETECTED' (B)(6) 2025 08:41:23 CRITICAL NO LOCATION PATCHES DETECTED' (B)(6) 2025 08:41:38 CRITICAL NO LOCATION PATCHES DETECTED' (B)(6) 2025 09:11:32 RFG CRITICAL PUMP PURGE ACTIVE' (B)(6) 2025 09:12:45 RFG CRITICAL PUMP STOPPED' (B)(6) 2025 09:13:04 RFG CRITICAL PUMP PURGE ACTIVE' (B)(6) 2025 09:13:05 RFG CRITICAL PUMP STOPPED: BUBBLE DETECTED' (B)(6) 2025 09:13:14 RFG CRITICAL PUMP STOPPED: BUBBLE DETECTED' (B)(6) 2025 09:13:20 RFG CRITICAL PUMP STOPPED' (B)(6) 2025 09:13:25 RFG CRITICAL PUMP PURGE ACTIVE' (B)(6) 2025 09:13:47 RFG CRITICAL PUMP PURGE ACTIVE' (B)(6) 2025 09:14:10 RFG CRITICAL PUMP STOPPED' (B)(6) 2025 09:20:53 CRITICAL LOCATION REFERENCE MOVED' V 09:31:34 RFG CRITICAL RETURNS 1,2,3,4 CONTACT QUALITY POOR' (B)(6) 2025 09:31:34 RFG WARNING RETURN 1 CQM IMPEDANCE 40% INCREASE' (B)(6) 2025 09:31:34 RFG WARNING RETURN 2 CQM IMPEDANCE 40% INCREASE' (B)(6) 202509:31:34 RFG WARNING RETURN 3 CQM IMPEDANCE 40% INCREASE' (B)(6) 2025 09:31:34 RFG WARNING RETURN 4 CQM IMPEDANCE 40% INCREASE' (B)(6) 2025 09:36:35 CIU INFORMATION ABL CATHETER LOADING' (B)(6) 2025 09:36:45 RFG CRITICAL PUMP PURGE ACTIVE' (B)(6) 2025 09:36:57 RFG CRITICAL CATHETER PREP. SEQUENCE RUNNING' (B)(6) 2025 09:37:31 RFG CRITICAL PUMP PURGE ACTIVE' (B)(6) 2025 09:52:08 CRITICAL DATA SAVE FAULT' (B)(6) 2025 09:52:10 CIU CRITICAL PACING COMMUNICATIONS FAILURE' IN CONCLUSION, THE CLINICAL ISSUES, STROKE AND NEUROLOGICAL DEFICIT, CAN NOT BE CONFIRMED THROUGH DATA ANALYSIS. THE PHYSICAL PRODUCT WAS NOT RETURNED. 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.
IT WAS REPORTED THAT POST-OPERATIVE TO A CARDIAC ABLATION PROCEDURE, THE PATIENT EXPERIENCED A STROKE. IT WAS FURTHER REPORTED THAT THE PATIENT WAS FOUND TO HAVE NEUROLOGICAL DEFICIT SEVERAL HOURS AFTER THE PROCEDURE. IT WAS NOTED THAT THE PATIENT WOKE UP FROM ANESTHESIA FINE AND HAD NO DEFICITS IMMEDIATELY AFTER PROCEDURE. SEVERAL HOURS LATER THE PATIENT HAD DOUBLE VISION AFTER WAKING FROM SLEEP SEVERAL HOURS AFTER THE PROCEDURE WAS COMPLETED. MAGNETIC RESONANCE IMAGING (MRI) WAS CONDUCTED LATER THAT DAY AND REVEALED MULTIFOCAL PUNCTUATE ACUTE INFARCTS. THE PATIENT WAS SEEN BY NEUROLOGY, AND THE PATIENT'S HOSPITALIZATION WAS EXTENDED. ADDITIONALLY, IT WAS REPORTED THAT DURING THE PROCEDURE A LEFT WIDE ANTRAL CIRCUMFERENTIAL ABLATION (WACA) WAS PERFORMED WITH PULSED FIELD (PF), MITRAL LINE ABLATION WAS PERFORMED WITH RADIOFREQUENCY (RF), POSTERIOR WALL ISOLATION WITH PF, AND CAVOTRICUSPID ISTHMUS (CTI) LINE WITH RF. THE RIGHT VEINS WERE ISOLATED FROM A MAZE PROCEDURE. THE PROCEDURE WAS COMPLETED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1846684 | AFFERA | PERCUTANEOUS CARDIAC ABLATION CATHETER FOR TREATMENT OF ATRIAL FIBRILLATION WITH | QZI | MEDTRONIC, INC. | AFR-00001 | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 45 YR | Female | Hospitalization |