FARAWAVE NAV
Report
- Report Number
- 2124215-2025-82117
- Event Type
- Injury
- Date Received
- November 12, 2025
- Date of Event
- October 17, 2025
- Report Date
- March 18, 2026
- Manufacturer
- BOSTON SCIENTIFIC CORPORATION
- Product Code
- QZI
- UDI-DI
- 00191506043193
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MA, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
GOOD FAITH EFFORT ATTEMPTS WERE MADE TO TRY AND RETRIEVE ADDITIONAL DETAILS REGARDING THE REPORTED EVENT, BUT FURTHER INFORMATION WAS UNABLE TO BE OBTAINED.
DEVICE TECHNICAL ANALYSIS: THE DEVICE WAS NOT RETURNED FOR ANALYSIS; THEREFORE, A TECHNICAL ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. DEVICE HISTORY RECORD REVIEW: THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY, AND PERFORMANCE SPECIFICATIONS. LABELING REVIEW: BASED ON THE INFORMATION PROVIDED, THERE IS NO EVIDENCE THAT THE DEVICE WAS USED IN A MANNER INCONSISTENT WITH THE LABELLED INDICATIONS/INSTRUCTIONS FOR USE. RISK REVIEW: A RISK REVIEW PERFORMED FOR THE FARAWAVE NAV DEVICE CONFIRMED THAT THE EVENT OF HEMOLYSIS IS A KNOWN EVENT DEFINED IN THE PRODUCT RISK MANAGEMENT DOCUMENTATION. THIS EVENT TYPE HAS BEEN ACCOUNTED FOR DURING PRODUCT RISK ANALYSIS TO SUPPORT ACCEPTABLE RISK BENEFIT FOR THE PRODUCT. PRODUCT RISK BENEFIT INCLUDES CONSIDERATION OF RISK SEVERITY AND RATE, AND THE OVERALL RESIDUAL RISK OF THE FARAWAVE NAV DEVICE IS ACCEPTABLE. INVESTIGATION CONCLUSION: BASED ON THE INFORMATION PROVIDED, THE REPORTED EVENT OF HEMOLYSIS IS A KNOWN INHERENT RISKS OF THE FARAWAVE NAV DEVICE. HEMOLYSIS, IS AN EXPECTED PROCEDURAL COMPLICATION ADDRESSED WITHIN THE IFU FOR THE FARAWAVE NAV CATHETER. THERE WERE NO ALLEGATIONS OF A QUALITY OR MANUFACTURING DEFICIENCY LEADING TO THE ADVERSE EVENT AS REPORTED TO BSC, AND THE DEVICE HAS NOT BEEN RETURNED FOR ANALYSIS AT THIS TIME. D2A: COMMON DEVICE NAME: PERCUTANEOUS CARDIAC ABLATION CATHETER FOR TREATMENT OF ATRIAL FIBRILLATION WITH IRREVERSIBLE ELECTROPORATION; REPORTED HERE AS THE COMMON DEVICE NAME EXCEEDED THE CHARACTER LIMIT FOR DESIGNATED FIELD. - THIS FIELD IN THE ADDITIONAL MFR NARRATIVE FIELD IS CORRECTED AS IT WAS EXCLUDED FROM THE LAST REPORT. THE DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS. UPON RECEIPT AND COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.
D2A: COMMON DEVICE NAME: PERCUTANEOUS CARDIAC ABLATION CATHETER FOR TREATMENT OF ATRIAL FIBRILLATION WITH IRREVERSIBLE ELECTROPORATION; REPORTED HERE AS THE COMMON DEVICE NAME EXCEEDED THE CHARACTER LIMIT FOR DESIGNATED FIELD. - THIS FIELD IN THE ADDITIONAL MFR NARRATIVE FIELD IS CORRECTED AS IT WAS EXCLUDED FROM THE LAST REPORT. THE DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS. UPON RECEIPT AND COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.
B5: DESCRIBE EVENT OR PROBLEM: UPDATED. THE DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS. UPON RECEIPT AND COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.
IT WAS REPORTED THAT A PATIENT EXPERIENCED HEMOLYSIS FOLLOWING A PULSED FIELD ABLATION PROCEDURE WITH A FARAWAVE NAV CATHETER. DARK URINE LED TO CHECKING HEMOLYSIS BLOOD TESTS. NO FURTHER INFORMATION IS AVAILABLE.
IT WAS REPORTED THAT A PATIENT EXPERIENCED HEMOLYSIS FOLLOWING A PULSED FIELD ABLATION PROCEDURE WITH A FARAWAVE NAV CATHETER. DARK URINE LED TO CHECKING HEMOLYSIS BLOOD TESTS. NO FURTHER INFORMATION IS AVAILABLE. IT WAS FURTHER REPORTED THAT THE HEMOLYSIS ADVERSE EVENT WAS RESOLVED ON (B)(6) 2025. THE EVENT OCCURRED IN THE CONTEXT OF A REPEAT ABLATION PROCEDURE PERFORMED ON (B)(6) 2025.
IT WAS REPORTED THAT A PATIENT EXPERIENCED HEMOLYSIS FOLLOWING A PULSED FIELD ABLATION PROCEDURE WITH A FARAWAVE NAV CATHETER. DARK URINE LED TO CHECKING HEMOLYSIS BLOOD TESTS. NO FURTHER INFORMATION IS AVAILABLE. IT WAS FURTHER REPORTED THAT THE HEMOLYSIS ADVERSE EVENT WAS RESOLVED ON (B)(6) 2025. THE EVENT OCCURRED IN THE CONTEXT OF A REPEAT ABLATION PROCEDURE PERFORMED ON (B)(6) 2025.
IT WAS REPORTED THAT A PATIENT EXPERIENCED HEMOLYSIS FOLLOWING A PULSED FIELD ABLATION PROCEDURE WITH A FARAWAVE NAV CATHETER. DARK URINE LED TO CHECKING HEMOLYSIS BLOOD TESTS. NO FURTHER INFORMATION IS AVAILABLE. IT WAS FURTHER REPORTED THAT THE HEMOLYSIS ADVERSE EVENT WAS RESOLVED ON (B)(6) 2025. THE EVENT OCCURRED IN THE CONTEXT OF A REPEAT ABLATION PROCEDURE PERFORMED ON (B)(6) 2025.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 622870 | FARAWAVE NAV | CARDIAC IRREVERSIBLE ELECTROPORATION SYSTEM CATHETER | QZI | BOSTON SCIENTIFIC CORPORATION | 0037172662 | 00191506043193 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |