AFFERA
Report
- Report Number
- 9612164-2025-06001
- Event Type
- Malfunction
- Date Received
- December 3, 2025
- Date of Event
- November 10, 2025
- Report Date
- March 25, 2026
- Manufacturer
- MEDTRONIC IRELAND
- Product Code
- QZI
- UDI-DI
- 00763000973506
- 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: THE AFR-00001 CATHETER WITH LOT NUMBER 0012857238 WAS RETURNED AND ANALYZED. DURING EXTERNAL VISUAL INSPECTION, THE CATHETER WAS FOUND TO BE INTACT, AND NO DEFECTS WERE OBSERVED. THE CIRRIS TESTER WAS USED TO PERFORM SHORTS AND MAPPING TESTS, WHICH RESULTED IN A FAILURE. AN SHORT CIRCUIT WAS IDENTIFIED AT E1 TO NOZ OF THE CATHETER. AN OPTICAL INSPECTION OF THE LATTICE STRUCTURE WAS CONDUCTED, ALL THE WIRES FOUND TO BE INTACT, AND NO DEFECTS WERE OBSERVED. THE HANDLE WAS OPENED TO EXAMINE THE ELECTRODE WIRES INSIDE. ALL THE WIRES FOUND TO BE INTACT, AND NO DEFECTS WERE OBSERVED. THE CATHETER WAS CONNECTED TO THE FINAL FUNCTIONAL TESTER (E-052) FOR IMPEDANCE, NDI CALIBRATION AND THERMOCOUPLE TESTS. THE THREE TESTS PASSED SUCCESSFULLY. A MULTIMETER AND BREAKOUT FIXTURE (FXT-00161) WERE USED TO CHECK FOR SHORTS AT E1 TO NOZ, AND NO SHORTS WERE OBSERVED. THE SHORT CIRCUIT WAS IDENTIFIED AT E1 TO NOZ OF THE CATHETER DUE TO ELECTRICAL INTERMITTENCE. IN CONCLUSION, THE REPORTED ISSUES (STEAM POP AND "TEMPERATURE SPREAD TOO HIGH" ERROR) WERE NOT REPRODUCED DURING TESTING. THE CATHETER FAILED THE RETURNED PRODUCT INSPECTION DUE TO THE INTERMITTENCE ISSUE. 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 0012857238 WAS RETURNED AND ANALYZED. DURING EXTERNAL VISUAL INSPECTION, THE CATHETER WAS FOUND TO BE INTACT, AND NO DEFECTS WERE OBSERVED. THE CIRRIS TESTER WAS USED TO PERFORM SHORTS AND MAPPING TESTS, WHICH RESULTED IN A FAILURE. AN SHORT CIRCUIT WAS IDENTIFIED AT E1 TO NOZ OF THE CATHETER. AN OPTICAL INSPECTION OF THE LATTICE STRUCTURE WAS CONDUCTED, ALL THE WIRES FOUND TO BE INTACT, AND NO DEFECTS WERE OBSERVED. THE HANDLE WAS OPENED TO EXAMINE THE ELECTRODE WIRES INSIDE. ALL THE WIRES FOUND TO BE INTACT, AND NO DEFECTS WERE OBSERVED. THE CATHETER WAS CONNECTED TO THE FINAL FUNCTIONAL TESTER (E-052) FOR IMPEDANCE, NDI CALIBRATION AND THERMOCOUPLE TESTS. THE THREE TESTS PASSED SUCCESSFULLY. A MULTIMETER AND BREAKOUT FIXTURE (FXT-00161) WERE USED TO CHECK FOR SHORTS AT E1 TO NOZ, AND NO SHORTS WERE OBSERVED. IN CONCLUSION, THE REPORTED ISSUES (STEAM POP AND "TEMPERATURE SPREAD TOO HIGH" ERROR) WERE NOT REPRODUCED 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.
IT WAS REPORTED THAT DURING A CARDIAC ABLATION PROCEDURE DURING RADIOFREQUENCY LESION DELIVERY ON THE CAVOTRICUSPID ISTHMUS (CTI), A "TEMPERATURE SPREAD TOO HIGH" ERROR WAS DISPLAYED. THE CATHETER WAS REPOSITIONED AND ABLATION WAS ATTEMPTED AGAIN, BUT THE ERROR PERSISTED. THE PHYSICIAN WAS ABLE TO RESUME ABLATION SUCCESSFULLY AND IT WAS NOTED THAT THE PHYSICIAN OBSERVED A POTENTIAL STEAM POP ON INTRACARDIAC ECHOCARDIOGRAPHY (ICE) AFTER THE LESION. THE CASE CONTINUED WITHOUT FURTHER ERRORS. THE CASE WAS COMPLETED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2846699 | AFFERA | PERCUTANEOUS CARDIAC ABLATION CATHETER FOR TREATMENT OF ATRIAL FIBRILLATION WITH | QZI | MEDTRONIC IRELAND | AFR-00001 | 0012857238 | 00763000973506 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Male |