AFFERA
Report
- Report Number
- 3012520654-2025-00203
- Event Type
- Malfunction
- Date Received
- November 21, 2025
- Date of Event
- October 28, 2025
- Report Date
- March 27, 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
CORRECTION: H11 (ADDT. MANUFACTURER FOR MDR / PRODUCT EVENT SUMMARY) PRODUCT EVENT SUMMARY: OPTICAL INSPECTION OF THE LATTICE STRUCTURE ALSO IDENTIFIED A TRACE OF TISSUE INSIDE THE LATTICE. IN CONCLUSION, THE REPORTED TISSUE IN TIP ISSUE WAS CONFIRMED WITH THE RETURNED CATHETER. THE CATHETER DID NOT PASS THE RETURNED PRODUCT INSPECTION DUE TO THE PRESENCE OF TISSUE IN THE LATTICE AND AN OPEN CIRCUIT IN ZONE 1. 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 DATA FILES WERE RETURNED AND ANALYZED. THE LOG FILES RETURNED FROM THE FIELD WERE REVIEWED USING THE LOG FILES ANALYSIS TOOL. IN CONCLUSION, THE REPORTED "TEMPERATURE ACQUISITION CIRCUIT FAILURE' AND "PACING COMMUNICATIONS FAILURE" ISSUES WERE CONFIRMED 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 SPHERE 9 CATHETER WITH LOT 0232005963 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 OPEN CIRCUIT WAS IDENTIFIED AT P1 ELECTRODE IN ZONE 1 OF THE CATHETER. AN OPTICAL INSPECTION OF THE LATTICE STRUCTURE WAS CONDUCTED, AND REVEALED A BROKEN WIRE AT P1. IN CONCLUSION, THE REPORTED TISSUE IN TIP ISSUE WAS NOT OBSERVED WITH THE RETURNED CATHETER. THE CATHETER FAILED THE RETURNED PRODUCT INSPECTION DUE TO AN OPEN CIRCUIT IN ZONE 1. 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 USE OF THE SPHERE CATHETER IN A CARDIAC ABLATION PROCEDURE, AFTER COMPLETION OF THE LEFT PULMONARY VEIN ABLATION, THE CATHETER WAS MANIPULATED MORE ROUGHLY THAN USUAL, AND FOLLOWING A PULSED FIELD LESION, A HIGH TEMPERATURE WAS DETECTED ON ONE OF THE ELECTRODES. THE TEMPERATURE NORMALIZED BRIEFLY, BUT SUBSEQUENT PULSED FIELD LESIONS RESULTED IN TEMPERATURE SPIKES THAT EVENTUALLY REMAINED HIGH, PREVENTING FURTHER LESION DELIVERY. THE CATHETER WAS OBSERVED TO HAVE WHAT APPEARED TO BE TISSUE IN THE LATTICE. THE CATHETER WAS REPLACED. 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 |
|---|---|---|---|---|---|---|---|
| 2463585 | AFFERA | PERCUTANEOUS CARDIAC ABLATION CATHETER FOR TREATMENT OF ATRIAL FIBRILLATION WITH | QZI | MEDTRONIC, INC. | AFR-00001 | 0232005963 | 00763000973391 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |