AFFERA
Report
- Report Number
- 3012520654-2025-00122
- Event Type
- Injury
- Date Received
- August 28, 2025
- Date of Event
- July 31, 2025
- Report Date
- November 11, 2025
- Manufacturer
- MEDTRONIC, INC.
- Product Code
- QZI
- UDI-DI
- 00763000973384
- PMA / PMN Number
- P240013
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NL
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- 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: THE AFR-0001 SPHERE 9 CATHETER WITH (B)(6) AND DATA FILES WERE RETURNED AND ANALYZED. 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 THE SHORTS AND MAPPING TESTS, WHICH HAD PASSING RESULTS. A MULTIMETER AND A BREAKOUT FIXTURE (FXT-00161) WAS USED TO CHECK FOR ANY SHORTS TO BRAID, BUT NONE WERE FOUND. THE CATHETER WAS FUNCTIONALLY TESTED USING TEST CAPITAL EQUIPMENT. RADIOFREQUENCY AND PULSED FIELD ABLATIONS WERE COMPLETED SUCCESSFULLY WITH THE CATHETER. A NEW MAP WAS STARTED, AND THE CATHETER WAS ABLE TO MAP APPROPRIATELY. NO LOG DATA FILES WERE RETURNED FROM THE FIELD. THE REPORTED EVENT WAS ABOUT A CLINICAL ADVERSE EVENT THAT CANNOT BE ASSESSED THROUGH THE LOG DATA FILE ANALYSIS. IN CONCLUSION, THE REPORTED CLINICAL ISSUE (VENTRICULAR TACHYCARDIA (VT) OCCURRED DURING THE PROCEDURE. 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.
CONTINUATION OF D10: PRODUCT ID AFR-00003 (UNKNOWN SERIAL/LOT); PRODUCT TYPE: 2004-MAPPING HARDWARE. 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.
CORRECTION: B5. 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 LATER REPORTED THAT THE PATIENT'S ICD HAD TO BE EXCHANGED AS A RESULT OF THE EVENTS.
IT WAS REPORTED THAT DURING A CARDIAC ABLATION PROCEDURE FOR VENTRICULAR TACHYCARDIA (VT), THE ELECTROCARDIOGRAM (ECG) 1 INPUT DID NOT GIVE ANY SIGNAL. WHEN THE WINDOW OF INTEREST WAS MOVED, THE ACTIVATION MAP DID NOT PLAY AS EXPECTED UNTIL THE MAP WAS GATHERING NEW POINTS. SWITCHING TO "VOLTAGE," "SOLID," AND "ACTIVATION" DID NOT RESOLVE THE ISSUE. UPON PREPARATION OF A REMAP TO MAP THE PATIENT'S VENTRICULAR TACHYCARDIA, THE ANATOMY WAS SHOWN AS A BLACK IMAGE RATHER THAN THE EXPECTED GRAY IMAGE. WHEN MAPPING BEGAN, VISIBLE POINTS WERE UNABLE TO BE ACQUIRED. ADDITIONALLY, IT WAS NOTED THAT THE CLICK RESPONSE OF THE MOUSE WAS DELAYED AND INCONSISTENT. THE CASE WAS SHUT DOWN AND REOPENED, REVEALING MISSING DATA FROM PRIOR MAPS. THE WORKSTATION WAS REBOOTED AND A NEW PROCEDURE WAS STARTED WHICH RESOLVED THE ISSUES. IT WAS THEN REPORTED THAT WHEN ABLATING WITH RADIOFREQUENCY (RF) ON THE LEFT VENTRICULAR SEPTUM (IN THE PROXIMITY OF WHERE THE PATIENT'S RIGHT VENTRICULAR SHOCK LEAD OF THEIR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS LOCATED), VT WAS INDUCED, NECESSITATING EXTERNAL DIRECT CURRENT CARDIOVERSION (DCCV). FOLLOWING DCCV, A MAP SHIFT WAS OBSERVED, WITH ABLATION TAGS DISPLAYED FURTHER AWAY FROM THE ANATOMIC SHELL. THE CASE WAS COMPLETED. A POST-PROCEDURAL CHECKUP OF THE ICD REVEALED A SHOCK AND THAT THE PACE IMPEDANCE OF ALL LEADS WERE OUT OF RANGE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
A POST-PROCEDURAL CHECKUP OF THE ICD DID NOT REVEAL A SHOCK; THE CHECKUP REVEALED THAT THE SHOCKING LEADS AND PACING LEADS HAD ELEVATED IMPEDANCE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 235747 | AFFERA | PERCUTANEOUS CARDIAC ABLATION CATHETER FOR TREATMENT OF ATRIAL FIBRILLATION WITH | QZI | MEDTRONIC, INC. | AFR-00001 | 0230700616 | 00763000973384 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Male | Required Intervention |