FARAWAVE NAV
Report
- Report Number
- 2124215-2025-68408
- Event Type
- Malfunction
- Date Received
- October 3, 2025
- Date of Event
- September 12, 2025
- Report Date
- January 5, 2026
- Manufacturer
- BOSTON SCIENTIFIC CORPORATION
- Product Code
- QZI
- UDI-DI
- 00191506043193
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
D2A COMMON DEVICE NAME: PERCUTANEOUS CARDIAC ABLATION CATHETER FOR TREATMENT OF ATRIAL FIBRILLATION WITH IRREVERSIBLE ELECTROPORATION. E1 INITIAL REPORTER PHONE: (B)(6). DEVICE ANALYSIS: UPON RECEIPT AT A BOSTON SCIENTIFIC (BSC) POST MARKET QUALITY ASSURANCE LABORATORY, THE FARAWAVE NAV CATHETER WAS ANALYZED BY A BSC QUALITY INVESTIGATOR. DURING FUNCTIONAL TESTING, A TEST GUIDEWIRE WAS SUCCESSFULLY ADVANCED THROUGH THE RETURNED FARAWAVE NAV CATHETER GUIDEWIRE LUMEN WITH NO UNUSUAL RESISTANCE NOTED. THE FARAWAVE NAV CATHETER WAS DEPLOYED INTO BASKET AND FLOWER CONFIGURATIONS WITHOUT DIFFICULTY. WITH THE FARAWAVE NAV CATHETER DEPLOYED IN FLOWER CONFIGURATION A TEST GUIDEWIRE WAS ABLE TO BE MANEUVERED AS EXPECTED WITHIN THE GUIDEWIRE LUMEN. BASED ON ANALYSIS OF THE RETURNED FARAWAVE NAV CATHETER, THE REPORTED EVENT OF GUIDEWIRE STUCK WAS UNABLE TO BE CONFIRMED.
IT WAS INDICATED THAT THE DEVICE WILL BE RETURNED FOR EVALUATION. IF THERE IS ANY FURTHER RELEVANT INFORMATION OBTAINED, A SUPPLEMENTAL MEDWATCH WILL BE FILED.
IT WAS REPORTED THAT A STUCK GUIDEWIRE OCCURRED. A PULSE FIELD ABLATION PROCEDURE FOR ATRIAL FIBRILLATION WAS PERFORMED USING FARAWAVE CATHETER. A 31MM FARAWAVE NAV CATHETER WAS LOADED ONTO AN UNKNOWN STARTER WIRE AND THE FARAWAVE NAV CATHETER WAS ADVANCED INTO POSITION IN THE LEFT ATRIUM. PULSE FIELD ABLATION WAS PERFORMED ON THE LEFT PULMONARY VEINS. WHEN CANNULATING TO THE RIGHT PULMONARY VEINS THE GUIDEWIRE BECAME STUCK. THE GUIDEWIRE WAS REMOVED FROM THE FARAWAVE NAV CATHETER WITH SOME RESISTANCE AND THE PROCEDURE WAS COMPLETED WITH A NEW GUIDEWIRE.
IT WAS REPORTED THAT A STUCK GUIDEWIRE OCCURRED. A PULSE FIELD ABLATION PROCEDURE FOR ATRIAL FIBRILLATION WAS PERFORMED USING FARAWAVE CATHETER. A 31MM FARAWAVE NAV CATHETER WAS LOADED ONTO AN UNKNOWN STARTER WIRE AND THE FARAWAVE NAV CATHETER WAS ADVANCED INTO POSITION IN THE LEFT ATRIUM. PULSE FIELD ABLATION WAS PERFORMED ON THE LEFT PULMONARY VEINS. WHEN CANNULATING TO THE RIGHT PULMONARY VEINS THE GUIDEWIRE BECAME STUCK. THE GUIDEWIRE WAS REMOVED FROM THE FARAWAVE NAV CATHETER WITH SOME RESISTANCE AND THE PROCEDURE WAS COMPLETED WITH A NEW GUIDEWIRE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 235345 | FARAWAVE NAV | SEE H11 | QZI | BOSTON SCIENTIFIC CORPORATION | 0036639320 | 00191506043193 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |