AFFERA
Report
- Report Number
- 3012520654-2025-00197
- Event Type
- Malfunction
- Date Received
- November 19, 2025
- Date of Event
- September 16, 2025
- Report Date
- January 21, 2026
- Manufacturer
- MEDTRONIC, INC.
- Product Code
- QZI
- UDI-DI
- 00763000973391
- PMA / PMN Number
- P240013
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
PRODUCT EVENT SUMMARY: DATA FILES WERE RETURNED AND ANALYZED. CASE FILES WERE RETURNED AND REVIEWED. THE REPORTED SENSING/SIGNAL ISSUE IS PLAUSIBLE THROUGH DATA 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 CATHETER WITH LOT NUMBER 0231071703 WAS RETURNED AND ANALYZED. DURING EXTERNAL VISUAL INSPECTION, THE CATHETER WAS FOUND TO BE INTACT AND A VERY SMALL AMOUNT OF FOREIGN MATERIAL WAS SEEN ATTACHED TO THE TIP OF THE LATTICE OF THE CATHETER. CONFIRMED MATERIAL WAS ON THE TIP OF THE CATHETER. A MULTIMETER AND BREAKOUT FIXTURE (FXT-00161) WERE USED TO CHECK FOR SHORTS TO THE BRAID, NO SHORTS WERE IDENTIFIED. A DETAILED INSPECTION OF THE LATTICE STRUCTURE WAS CONDUCTED, AND EVIDENCE CORRESPONDING TO THE OPEN CIRCUITS IDENTIFIED DURING THE SHORTS AND MAPPING TESTS WERE CAPTURED. IN CONCLUSION, THE REPORTED ISSUES (LOCAL IMPEDANCE GRAPH WAS MAXED OUT, AND THE DISKS/ELECTRODES ON THE CATHETER APPEARED BRIGHT WHITE AND LARGE) WAS NOT CONFIRMED THROUGH TESTING AND ANALYSIS. THE CATHETER FAILED RETURN INSPECTION DUE TO MATERIAL ON THE TIP OF THE 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.
IT WAS REPORTED THAT DURING A CARDIAC ABLATION PROCEDURE, THE LOCAL IMPEDANCE GRAPH WAS MAXED OUT, AND THE DISKS/ELECTRODES ON THE CATHETER APPEARED BRIGHT WHITE AND LARGE. IT WAS NOTED THAT IT WAS POSSIBLE THE CATHETER WAS STUCK IN A SMALL VEIN. INTRACARDIAC ECHOCARDIOGRAPHY (ICE) WAS USED TO CONFIRM THE CATHETER POSITION IN THE LEFT ATRIUM. THE CATHETER EXTENSION CABLE WAS REPLACED AND THE ISSUE REMAINED. EVENTUALLY, THE CATHETER WAS REPLACED AND IT WAS FURTHER THAT THE ELECTRODES/MINIS HAD LOCAL IMPEDANCE FEEDBACK AFTER THE CATHETER SWITCH. THE CASE WAS COMPLETED WITH THE REPLACEMENT CATHETER. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 171053 | AFFERA | PERCUTANEOUS CARDIAC ABLATION CATHETER FOR TREATMENT OF ATRIAL FIBRILLATION WITH | QZI | MEDTRONIC, INC. | AFR-00001 | 0231071703 | 00763000973391 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Female | AFR-00001 CATHETER |