AFFERA
Report
- Report Number
- 9612164-2025-03900
- Event Type
- Injury
- Date Received
- August 8, 2025
- Date of Event
- July 23, 2025
- Report Date
- November 3, 2025
- Manufacturer
- MEDTRONIC IRELAND
- Product Code
- QZI
- UDI-DI
- 00763000973506
- PMA / PMN Number
- P240013
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- VA, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
PRODUCT EVENT SUMMARY: THE AFR-00001 SPHERE 9 CATHETER WITH LOT 0012794956 WAS RETURNED AND ANALYZED. DURING THE EXTERNAL VISUAL INS PECTION, THE CATHETER WAS CONFIRMED TO BE INTACT WITH NO OBSERVED DEFECTS. ADDITIONALLY, NO TISSUE OR FOREIGN MATERIAL WAS DETECTED ON OR INSIDE THE NITINOL SPHERE. THE CIRRIS TESTER WAS USED TO PERFORM SHORTS AND MAPPING TESTS, WHICH RESULTED IN A FAILURE. AN OPEN CIRCUIT WAS IDENTIFIED AT P4 ELECTRODE. A MULTIMETER AND BREAKOUT FIXTURE 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 "TISSUE IN TIP" WAS NOT CONFIRMED THROUGH TESTING. THE CATHETER FAILED THE RETURNED PRODUCT INSPECTION DUE TO AN OPEN CIRCUIT. 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: TWO IMAGES WERE RETURNED AND ANALYZED. TWO IMAGES FROM THE FIELD WERE RETURNED. ONE WAS THE HEPARIN PROTOCOL TRACKING FORM, AND THE OTHER SHOWED THE NITINOL SPHERE OF A SPHERE 9 CATHETER. A FOREIGN MATERIAL OR TISSUE WAS OBSERVED WITHIN THE LATTICE. IN CONCLUSION, THE MATERIAL IN THE TIP WAS CONFIRMED THROUGH ANALYSIS OF THE IMAGE. THE PHYSICAL PRODUCT IS YET TO BE ANALYZED. 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 LATER REPORTED THAT THE MATERIAL INSIDE THE THE LATTICE OF THE CATHETER WAS LOOSE, SMALL, AND DARK RED. FIVE FOLLOW-UP DOSES OF BLOOD THINNER MEDICATION WAS REQUIRED.
IT WAS REPORTED THAT DURING USE OF THE SPHERE-9 CATHETER IN A CARDIAC ABLATION PROCEDURE, CHAR AND THROMBUS FORMATION WERE OBSERVED. THE DEVICE WAS PLACED IN THE LEFT ATRIUM AFTER AN ACTIVATED CLOTTING TIME (ACT) OF 343, DESPITE A RECOMMENDATION TO WAIT UNTIL THE ACT REACHED 350. AFTER INITIAL MAPPING, THE PATIENT EXPERIENCED A DROP IN BLOOD PRESSURE AND TACHYCARDIA. NO EFFUSION WAS DETECTED. THESE SYMPTOMS WERE EVENTUALLY SUSPECTED TO BE A REACTION TO THE ANTICOAGULANT. THE SPHERE-9 CATHETER REMAINED IN THE LEFT ATRIUM DURING THIS PERIOD, WITH NO WORK BEING PERFORMED. TWENTY-FOUR MINUTES LATER, THE ACT MEASURED 262, PROMPTING IMMEDIATE REMOVAL OF THE SPHERE-9 CATHETER. UPON REMOVAL, A CLOT OR THROMBUS WAS OBSERVED INSIDE THE LATTICE OF THE DEVICE. THE SPHERE-9 CATHETER WAS REPLACED, AND THE PATIENT WAS GIVEN A BLOOD THINNER MEDICATION. ACT MEASUREMENTS CONTINUED THROUGHOUT THE PROCEDURE. THE PATIENT STABILIZED, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO FURTHER ISSUES. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 227336 | AFFERA | PERCUTANEOUS CARDIAC ABLATION CATHETER FOR TREATMENT OF ATRIAL FIBRILLATION WITH | QZI | MEDTRONIC IRELAND | AFR-00001 | 0012794956 | 00763000973506 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Required Intervention |