FARAWAVE
Report
- Report Number
- 2124215-2025-64562
- Event Type
- Malfunction
- Date Received
- September 18, 2025
- Date of Event
- September 12, 2025
- Report Date
- February 3, 2026
- Manufacturer
- BOSTON SCIENTIFIC CORPORATION
- Product Code
- QZI
- UDI-DI
- 00191506043216
- 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. DEVICE ANALYSIS: UPON RECEIPT AT A BOSTON SCIENTIFIC (BSC) POST MARKET QUALITY ASSURANCE LABORATORY, THE FARAWAVE CATHETER WAS ANALYZED BY A BSC QUALITY INVESTIGATOR. THE FARAWAVE CATHETER WAS VISUALLY AND FUNCTIONALLY EXAMINED. VISUAL INSPECTION IDENTIFIED WHITE MARKS AND/OR SPOTS ON THE CATHETER HANDLE. THE WHITE MARKS OR SPOTS WERE IDENTIFIED AS POTENTIALLY BEING ADHESIVE. DURING FUNCTIONAL TESTING A GUIDEWIRE WAS SUCCESSFULLY INSERTED INTO THE FARAWAVE CATHETER. CATHETER DEPLOYMENT WAS TESTED REPEATEDLY AND THE DEVICE WAS DEPLOYED INTO BASKET AND FLOWER CONFIGURATIONS WITH NO UNUSUAL RESISTANCE. BASED ON ANALYSIS OF THE RETURNED FARAWAVE CATHETER, THE REPORTED FOREIGN MATERIAL PRESENT ON DEVICE WAS ABLE TO BE CONFIRMED.
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 FOREIGN MATERIAL WAS PRESENT ON THE DEVICE. DURING PREPARATION FOR A PULSE FIELD ABLATION PROCEDURE, A FARAWAVE NAV CATHETER WAS SELECTED FOR USE. WHEN THE FARAWAVE NAV CATHETER WAS REMOVED FROM PACKAGING, WHITE POWDER-LIKE STAINS WERE OBSERVED ON THE DEVICE. A SECOND FARAWAVE NAV CATHETER OF THE SAME LOT NUMBER WAS SELECTED FOR USE AND UPON REMOVAL FROM PACKAGING, WHITE POWDER-LIKE STAINS WERE OBSERVED ON THE DEVICE. A FARAWAV NAV CATHETER OF A DIFFERENT LOT NUMBER WAS SELECTED FOR USE AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO PATIENT COMPLICATIONS WERE REPORTED.
IT WAS REPORTED THAT FOREIGN MATERIAL WAS PRESENT ON THE DEVICE. DURING PREPARATION FOR A PULSE FIELD ABLATION PROCEDURE, A FARAWAVE NAV CATHETER WAS SELECTED FOR USE. WHEN THE FARAWAVE NAV CATHETER WAS REMOVED FROM PACKAGING, WHITE POWDER-LIKE STAINS WERE OBSERVED ON THE DEVICE. A SECOND FARAWAVE NAV CATHETER OF THE SAME LOT NUMBER WAS SELECTED FOR USE AND UPON REMOVAL FROM PACKAGING, WHITE POWDER-LIKE STAINS WERE OBSERVED ON THE DEVICE. A FARAWAV NAV CATHETER OF A DIFFERENT LOT NUMBER WAS SELECTED FOR USE AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO PATIENT COMPLICATIONS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1730861 | FARAWAVE | SEE H11 | QZI | BOSTON SCIENTIFIC CORPORATION | 0036487528 | 00191506043216 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |