FARAWAVE
Report
- Report Number
- 2124215-2025-90925
- Event Type
- Malfunction
- Date Received
- December 15, 2025
- Date of Event
- November 25, 2025
- Report Date
- January 16, 2026
- Manufacturer
- BOSTON SCIENTIFIC CORPORATION
- Product Code
- QZI
- UDI-DI
- 00191506043148
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
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. DEVICE EVALUATED BY MFR.: UPON RECEIPT AT BOSTON SCIENTIFIC'S POST MARKET LABORATORY, THE FARAWAVE CATHETER WAS VISUALLY INSPECTED. VISUAL INSPECTION OF THE DEVICE NOTED WHITE MARKS ON THE CATHETER, WHICH INDICATED POTENTIAL ADHESIVE. THUS, THE REPORTED EVENT OF FOREIGN MATERIAL WAS CONFIRMED VIA ANALYSIS.
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. 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 FOR A PULMONARY VEIN ISOLATION PROCEDURE TO TREAT AN ATRIAL FIBRILLATION WITH FE, A FARAWAVE CATHETER WAS SELECTED FOR USE. DURING CATHETER PREPARATION, UPON OPENING THE DEVICE, THE CATHETER WAS VISIBLY SOILED WITH WHITE CONTAMINATION. THE DEVICE WAS REPLACED, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. IT WAS REPORTED THAT THE ORIGINAL DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED. THE DEVICE HAS BEEN RECEIVED AT BOSTON SCIENTIFIC'S POST MARKET LABORATORY WHERE IT IS AWAITING ANALYSIS. IT WAS FURTHER CONFIRMED THAT THE DEVICE WAS NOT USED AS IT WAS REPLACED BY A NEW DEVICE TO COMPLETE THE PROCEDURE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT ISSUES.
IT WAS REPORTED THAT FOR A PULMONARY VEIN ISOLATION PROCEDURE TO TREAT AN ATRIAL FIBRILLATION WITH FE, A FARAWAVE CATHETER WAS SELECTED FOR USE. DURING CATHETER PREPARATION, UPON OPENING THE DEVICE, THE CATHETER WAS VISIBLY SOILED WITH WHITE CONTAMINATION. THE DEVICE WAS REPLACED, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. IT WAS REPORTED THAT THE ORIGINAL DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED. THE DEVICE IS EXPECTED TO BE RETURNED FOR ANALYSIS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 273348 | FARAWAVE | NO MATCH | QZI | BOSTON SCIENTIFIC CORPORATION | 0037336338 | 00191506043148 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 76 YR | Male |