FARAWAVE
Report
- Report Number
- 2124215-2025-15891
- Event Type
- Injury
- Date Received
- March 13, 2025
- Date of Event
- February 25, 2025
- Report Date
- June 12, 2025
- Manufacturer
- BOSTON SCIENTIFIC CORPORATION
- Product Code
- QZI
- UDI-DI
- 00191506043148
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
CORRECTION TO SECTION H6 PATIENT CODES, CODE E060101 WAS ADDED. DETAILED PRODUCT INFORMATION WAS NOT PROVIDED TO BSC. IT WAS NOT AVAILABLE BECAUSE THE DEVICE WAS DISCARDED. BECAUSE THE PRODUCT IS UNKNOWN, WE ARE UNABLE TO PROVIDE THE UNIQUE IDENTIFIER (UDI) AND OTHER SPECIFIC PRODUCT INFORMATION. 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.
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.
ADDITIONAL INFORMATION WAS PROVIDED IN SECTION B5 DESCRIBE EVENT OR PROBLEM DETAILED PRODUCT INFORMATION WAS NOT PROVIDED TO BSC. IT WAS NOT AVAILABLE BECAUSE THE DEVICE WAS DISCARDED. BECAUSE THE PRODUCT IS UNKNOWN, WE ARE UNABLE TO PROVIDE THE UNIQUE IDENTIFIER (UDI) AND OTHER SPECIFIC PRODUCT INFORMATION. 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.
IT WAS REPORTED THAT THE PATIENT EXPERIENCED ATRIAL FIBRILLATION. THE PHYSICIAN HAD COMPLETED A PULMONARY VEIN ISOLATION AND POSTERIOR WALL ABLATION WITH A FARAWAVE PULSED FIELD ABLATION (PFA) CATHETER. ONCE THE PROCEDURE WAS COMPLETED, THE PATIENT WAS STILL IN ATRIAL FIBRILLATION, THEREFORE THE PHYSICIAN DECIDED TO CARDIOVERT THE PATIENT. A SYNCHRONIZED SHOCK WAS PERFORMED AT 360 JOULE SHOCK. UPON COMPLETION, THE PATIENT HAD NO UNDERLYING RHYTHM. PERCUTANEOUS PACING WAS PERFORMED FOR 40 MINUTES WITH CHECKS EVERY 5 MINUTES TO SEE IF THERE WAS A RHYTHM. NO UNDERLYING RHYTHM BECAME PRESENT. A PERMANENT PACEMAKER WAS PLACED IMMEDIATELY FOLLOWING PROCEDURE. THE PHYSICIAN DOES NOT BELIEVE PFA WAS THE CAUSE BUT WOULD LIKE A FOLLOW UP. THE PATIENT IS EXPECTED TO FULLY RECOVER. THE CATHETER IS NOT EXPECTED TO RETURN AS IT WAS DISPOSED THEREFORE THE LOT NUMBER IS NOT AVAILABLE.
IT WAS REPORTED THAT THE PATIENT EXPERIENCED ATRIAL FIBRILLATION. THE PHYSICIAN HAD COMPLETED A PULMONARY VEIN ISOLATION AND POSTERIOR WALL ABLATION WITH A FARAWAVE PULSED FIELD ABLATION (PFA) CATHETER. ONCE THE PROCEDURE WAS COMPLETED, THE PATIENT WAS STILL IN ATRIAL FIBRILLATION, THEREFORE THE PHYSICIAN DECIDED TO CARDIOVERT THE PATIENT. A SYNCHRONIZED SHOCK WAS PERFORMED AT 360 JOULE SHOCK. UPON COMPLETION, THE PATIENT HAD NO UNDERLYING RHYTHM. PERCUTANEOUS PACING WAS PERFORMED FOR 40 MINUTES WITH CHECKS EVERY 5 MINUTES TO SEE IF THERE WAS A RHYTHM. NO UNDERLYING RHYTHM BECAME PRESENT. A PERMANENT PACEMAKER WAS PLACED IMMEDIATELY FOLLOWING PROCEDURE. THE PHYSICIAN DOES NOT BELIEVE PFA WAS THE CAUSE BUT WOULD LIKE A FOLLOW UP. THE PATIENT IS EXPECTED TO FULLY RECOVER. THE CATHETER IS NOT EXPECTED TO RETURN AS IT WAS DISPOSED THEREFORE THE LOT NUMBER IS NOT AVAILABLE.
IT WAS REPORTED THAT THE PATIENT EXPERIENCED ATRIAL FIBRILLATION. THE PHYSICIAN HAD COMPLETED A PULMONARY VEIN ISOLATION AND POSTERIOR WALL ABLATION WITH A FARAWAVE PULSED FIELD ABLATION (PFA) CATHETER. ONCE THE PROCEDURE WAS COMPLETED, THE PATIENT WAS STILL IN ATRIAL FIBRILLATION, THEREFORE THE PHYSICIAN DECIDED TO CARDIOVERT THE PATIENT. A SYNCHRONIZED SHOCK WAS PERFORMED AT 360 JOULE SHOCK. UPON COMPLETION, THE PATIENT HAD NO UNDERLYING RHYTHM. PERCUTANEOUS PACING WAS PERFORMED FOR 40 MINUTES WITH CHECKS EVERY 5 MINUTES TO SEE IF THERE WAS A RHYTHM. NO UNDERLYING RHYTHM BECAME PRESENT. A PERMANENT PACEMAKER WAS PLACED IMMEDIATELY FOLLOWING PROCEDURE. THE PHYSICIAN DOES NOT BELIEVE PFA WAS THE CAUSE BUT WOULD LIKE A FOLLOW UP. THE PATIENT IS EXPECTED TO FULLY RECOVER. THE CATHETER IS NOT EXPECTED TO RETURN AS IT WAS DISPOSED THEREFORE THE LOT NUMBER IS NOT AVAILABLE. IT WAS FURTHER CONFIRMED THAT THE PATIENT HAD SINUS ARREST AND THE PATIENT WAS PERSISTENT ATRIAL FIBRILLATION FOR APPROXIMATELY 2 YEARS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1331456 | FARAWAVE | CARDIAC IRREVERSIBLE ELECTROPORATION SYSTEM CATHETER | QZI | BOSTON SCIENTIFIC CORPORATION | 00191506043148 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Required Intervention| O |