FARAWAVE
Report
- Report Number
- 2124215-2026-00964
- Event Type
- Injury
- Date Received
- January 7, 2026
- Date of Event
- November 1, 2025
- Report Date
- April 27, 2026
- Manufacturer
- FARAPULSE, INC.
- Product Code
- QZI
- UDI-DI
- 00810087180096
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CH
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
DUE TO ADDITIONAL INFORMATION RECEIVED, THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED FOR THE UPDATED FIELD DESCRIBE EVENT OR PROBLEM (B5), IN SECTION B - ADVERSE EVENT OR PRODUCT PROBLEM. CORRECTION TO THE INITIAL MDR IN BLOCK(S) PATIENT IDENTIFIER (A1), IN SECTION A - PATIENT 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. WE ARE UNABLE TO PROVIDE THE COMPLETE UNIQUE IDENTIFIER (UDI) AT THE TIME OF THE SUBMISSION OF THIS REPORT, AS IT WAS NOT YET AVAILABLE. IF ADDITIONAL DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. 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.
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. WE ARE UNABLE TO PROVIDE THE COMPLETE UNIQUE IDENTIFIER (UDI) AT THE TIME OF THE SUBMISSION OF THIS REPORT, AS IT WAS NOT YET AVAILABLE. IF ADDITIONAL DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. 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.
IT WAS REPORTED THE PATIENT EXPERIENCED A PERICARDIAL EFFUSION. ON (B)(6) 2025, AN ORAL MEDICATION WAS REQUIRED TO BE CHANGED/ADJUSTED (SUSPEND ANTICOAGULANT MEDICATION). THE PATIENT WAS HOSPITALIZED ON (B)(6) 2025. A FARAWAVE ABLATION CATHETER WAS SELECTED FOR USE FOR A CLINICAL ABLATION PROCEDURE OCCURRED ON (B)(6) 2025. A PERICARDIAL EFFUSION WAS REPORTED. AN ULTRASOUND/ECHOCARDIOGRAM/TEE/TTE WAS PERFORMED. NO FURTHER INFORMATION WAS PROVIDED. PRODUCT RETURN IS NOT EXPECTED. IT WAS FURTHER REPORTED THAT THE PATIENT WAS DISCHARGE FROM HOSPITAL AT (B)(6) 2025. IT WAS NOTED THAT THE FARAWAVE CATHETER IS NOT RELATED TO THE PERICARDIAL EFFUSION. PERICARDIAL EFFUSION IS ASSOCIATED WITH TRANSSEPTAL PUNCTURE, AND THE BOSTON SCIENTIFIC PFA CATHETER DOES NOT PERFORM TRANSSEPTAL PUNCTURE; THEREFORE, THERE IS NO CORRELATION BETWEEN THEM. PERICARDIAL EFFUSION WAS IDENTIFIED DURING ROUTINE IMAGING/MONITORING. IT IS CURRENTLY CONSIDERED TO BE POTENTIALLY RELATED TO INTRA-PROCEDURAL TRANSSEPTAL PUNCTURE BUT NOT RELATED TO THE FARAWAVE CATHETER. THE MEASURE TAKEN WAS TEMPORARY SUSPENSION OF ANTICOAGULANT MEDICATION. NO OTHER INTERVENTIONS ARE REQUIRED AT PRESENT. IT IS CONFIRMED THAT THIS EVENT IS NOT RELATED TO THE FARAWAVE CATHETER AND DOES NOT CONSTITUTE A DEVICE DEFICIENCY; THEREFORE, RETURN OF THE CATHETER IS NOT REQUIRED.
IT WAS REPORTED THE PATIENT EXPERIENCED A PERICARDIAL EFFUSION. ON (B)(6) 2025, AN ORAL MEDICATION WAS REQUIRED TO BE CHANGED/ADJUSTED (SUSPEND ANTICOAGULANT MEDICATION). THE PATIENT WAS HOSPITALIZED ON (B)(6) 2025. A FARAWAVE ABLATION CATHETER WAS SELECTED FOR USE FOR A CLINICAL ABLATION PROCEDURE OCCURRED ON (B)(6) 2025. A PERICARDIAL EFFUSION WAS REPORTED. AN ULTRASOUND/ECHOCARDIOGRAM/TEE/TTE WAS PERFORMED. NO FURTHER INFORMATION WAS PROVIDED. PRODUCT RETURN IS NOT EXPECTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 490994 | FARAWAVE | NO MATCH | QZI | FARAPULSE, INC. | 0036415655 | 00810087180096 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |