FARAWAVE NAV
Report
- Report Number
- 2124215-2025-67566
- Event Type
- Injury
- Date Received
- October 15, 2025
- Date of Event
- September 23, 2025
- Report Date
- November 13, 2025
- Manufacturer
- BOSTON SCIENTIFIC CORPORATION
- Product Code
- QZI
- UDI-DI
- 00191506043216
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AZ, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
IT WAS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION. IF THERE IS ANY FURTHER RELEVANT INFORMATION OBTAINED, A SUPPLEMENTAL MEDWATCH WILL BE FILED.
TWO (2) PHOTOGRAPHS OF INTRACARDIAC RECORDINGS WERE PROVIDED TO ASSIST IN THE INVESTIGATION AND WERE REVIEWED BY A BOSTON SCIENTIFIC QUALITY INVESTIGATOR. THE PROVIDED IMAGES SHOWED INTRACARDIAC RECORDS AFTER THE USE OF THE FARAWAVE NAV CATHETER AND TRANSIENT ST SEGMENT ELEVATION WAS NOTED POST-SHOCK. BASED ON THE INVESTIGATION AND MEDIA INSPECTION THE REPORTED ST SEGMENT ELEVATION WAS CONFIRMED.
IT WAS REPORTED THAT ST SEGMENT ELEVATION OCCURRED. A PULSE FIELD ABLATION PROCEDURE FOR PERSISTENT ATRIAL FIBRILLATION WAS PERFORMED USING A FARAWAVE NAV CATHETER. THE FARAWAVE NAV CATHETER WAS ADVANCED THROUGH A FARADRIVE SHEATH TO THE LEFT ATRIUM. DURING THE THIRD APPLICATION OF ABLATION TO THE LEFT SUPERIOR PULMONARY VEIN ST SEGMENT ELEVATION WAS OBSERVED VIA ELECTROCARDIOGRAM LEAD AVF AND 200 MICROGRAMS OF NITROGLYCERIN WERE ADMINISTERED IN RESPONSE. THE PATIENT FULLY RECOVERED AND THE PROCEDURE WAS COMPLETED. THE PATIENT WAS DISCHARGED POST INDEX PROCEDURE.
IT WAS REPORTED THAT ST SEGMENT ELEVATION OCCURRED. A PULSE FIELD ABLATION PROCEDURE FOR PERSISTENT ATRIAL FIBRILLATION WAS PERFORMED USING A FARAWAVE NAV CATHETER. THE FARAWAVE NAV CATHETER WAS ADVANCED THROUGH A FARADRIVE SHEATH TO THE LEFT ATRIUM. DURING THE THIRD APPLICATION OF ABLATION TO THE LEFT SUPERIOR PULMONARY VEIN ST SEGMENT ELEVATION WAS OBSERVED VIA ELECTROCARDIOGRAM LEAD AVF AND 200 MICROGRAMS OF NITROGLYCERIN WERE ADMINISTERED IN RESPONSE. THE PATIENT FULLY RECOVERED AND THE PROCEDURE WAS COMPLETED. THE PATIENT WAS DISCHARGED POST INDEX PROCEDURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2694966 | FARAWAVE NAV | CARDIAC IRREVERSIBLE ELECTROPORATION SYSTEM CATHETER | QZI | BOSTON SCIENTIFIC CORPORATION | 0036909297 | 00191506043216 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 76 YR | Male | Required Intervention |