FARAWAVE NAV
Report
- Report Number
- 2124215-2026-15640
- Event Type
- Malfunction
- Date Received
- March 20, 2026
- Date of Event
- February 26, 2026
- Report Date
- May 27, 2026
- Manufacturer
- BOSTON SCIENTIFIC CORPORATION
- Product Code
- QZI
- UDI-DI
- 00191506043216
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GA, 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. INVESTIGATION SUMMARY: WITH ALL THE AVAILABLE INFORMATION, BOSTON SCIENTIFIC IS UNABLE TO CONFIRM CAUSE OF THE REPORTED CLINICAL OBSERVATION OF A STUCK GUIDEWIRE. THE DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS; THEREFORE, A TECHNICAL ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. DEVICE HISTORY RECORD REVIEW: IT WAS CONFIRMED THIS DEVICE MET SPECIFICATION PRIOR TO DISTRIBUTION AND THERE WERE NO MANUFACTURING DEVIATIONS WHICH COULD HAVE CONTRIBUTED TO THE REPORTED EVENT. DEVICE TECHNICAL ANALYSIS: IT WAS INDICATED THAT THE DEVICE WAS DISPOSED; THEREFORE, A TECHNICAL ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. RISK ASSESSMENT: A RISK REVIEW PERFORMED FOR THE FARAWAVE DEVICE CONFIRMED THAT THE EVENTS OF GUIDEWIRE STUCK AND TISSUE DAMAGE ARE KNOWN EVENTS DEFINED IN THE PRODUCT'S RISK MANAGEMENT DOCUMENTATION. THESE EVENT TYPES HAVE 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 DEVICE IS ACCEPTABLE. 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 (IFU). (WATCHOUT FOR UNINTENDED USE ERROR) INVESTIGATION CONCLUSION: THE KNOWN INHERENT RISK (KIR) OF DEVICE CAUSE CODE WAS SELECTED BASED ON THE INFORMATION PROVIDED WITHIN THE EVENT DESCRIPTION. THE REPORTED EVENTS OF GUIDEWIRE STUCK AND TISSUE DAMAGE ARE RECOGNIZED COMPLICATIONS ASSOCIATED WITH CATHETER-BASED ELECTROPHYSIOLOGY PROCEDURES AND ARE ADDRESSED WITHIN THE FARAWAVE IFU AND RISK MANAGEMENT DOCUMENTATION. THE GUIDEWIRE BECAME ENTRAPPED DUE TO OBSTRUCTION AT THE DISTAL TIP OF THE CATHETER, WHERE MATERIAL DESCRIBED AS TISSUE OR PLASTIC WAS OBSERVED. ALTHOUGH THE EXACT NATURE OF THE MATERIAL COULD NOT BE DETERMINED, THE MECHANISM IS CONSISTENT WITH KNOWN INHERENT RISKS OF CATHETER MANIPULATION AND GUIDEWIRE USE. THERE WERE NO ALLEGATIONS OR EVIDENCE OF DEVICE MALFUNCTION OR MANUFACTURING DEFICIENCY, AND THE DEVICE WAS NOT RETURNED FOR ANALYSIS. THE CATHETER WAS REPLACED, AND THE PROCEDURE WAS COMPLETED.
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. 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 THAT CATHETER GUIDEWIRE STUCK OCCURRED. IT WAS REPORTED THAT A FARAWAVE CATHETER WAS USED FOR AN ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE TO TREAT A PAROXYSMAL ATRIAL FIBRILLATION. THE CATHETER WAS PREPARED AND DURING THE PROCEDURE, THE LEFT VEIN WAS ABLATED AND WHEN THE PHYSICIAN ATTEMPTED TO PULL IN THE ROSEN GUIDEWIRE, IT BECAME JAMMED. TROUBLESHOOTING WAS PERFORMED; THE PHYSICIAN ATTEMPTED TO SPIN THE CATHETER FREE IN THE SHEATH. HOWEVER, UPON REMOVAL OF THE CATHETER, A PLASTIC OR TISSUE WAS NOTICED JAMMED IN THE DISTAL TIP OF THE CATHETER WHICH WAS NOT ALLOWING MOVEMENT OF THE GUIDEWIRE. THE CATHETER WAS REPLACED AND PROCEDURE WAS COMPLETED WITHOUT PATIENT COMPLICATIONS. THE GUIDEWIRE COULD BE REMOVED FROM THE CATHETER, BUT THE GUIDEWIRE BECAME KINKED. FURTHER INFORMATION WAS RECEIVED THAT THE GUIDEWIRE AND CATHETER WERE PREPARED ON BACK TABLE WITH NO ISSUES OR MALFUNCTIONS. AFTER ABLATING THE LEFT SUPERIOR PULMONARY VEIN, THE GUIDEWIRE BECAME JAMMED AND THE PHYSICIAN WAS UNABLE TO MOVE ABOUT LEFT ATRIUM SAFELY. PHYSICIAN HAD TO USE MORE FORCE THAN COMFORTABLE TO REMOVE THE GUIDEWIRE FROM THE CATHETER. A PIECE OF PLASTIC OR TISSUE, IT WAS NOT POSSIBLE TO DETERMINE WHAT IT WAS, WAS JAMMED IN THE TIP OF THE CATHETER CAUSING THE GUIDEWIRE TO BE JAMMED. THERE WERE NO ISSUES WITH THE ABILITY TO DEPLOY OR UNDEPLOY THE CATHETER AT THE BEGINNING, BUT DEFINITELY AFTER ABLATING LEFT SUPERIOR VEIN THE GUIDEWIRE BECAME LINKED AFTER FINALLY REMOVING IT FROM THE CATHETER. NO OTHER ISSUES OR MALFUNCTIONS WERE PRESENT. A NEW GUIDEWIRE AND CATHETER WERE USED TO COMPLETE THE CASE.
IT WAS REPORTED THAT CATHETER GUIDEWIRE STUCK OCCURRED. IT WAS REPORTED THAT A FARAWAVE CATHETER WAS USED FOR AN ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE TO TREAT A PAROXYSMAL ATRIAL FIBRILLATION. THE CATHETER WAS PREPARED AND DURING THE PROCEDURE, THE LEFT VEIN WAS ABLATED AND WHEN THE PHYSICIAN ATTEMPTED TO PULL IN THE ROSEN GUIDEWIRE, IT BECAME JAMMED. TROUBLESHOOTING WAS PERFORMED; THE PHYSICIAN ATTEMPTED TO SPIN THE CATHETER FREE IN THE SHEATH. HOWEVER, UPON REMOVAL OF THE CATHETER, A PLASTIC OR TISSUE WAS NOTICED JAMMED IN THE DISTAL TIP OF THE CATHETER WHICH WAS NOT ALLOWING MOVEMENT OF THE GUIDEWIRE. THE CATHETER WAS REPLACED AND PROCEDURE WAS COMPLETED WITHOUT PATIENT COMPLICATIONS. THE GUIDEWIRE COULD BE REMOVED FROM THE CATHETER, BUT THE GUIDEWIRE BECAME KINKED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 230418 | FARAWAVE NAV | NO MATCH | QZI | BOSTON SCIENTIFIC CORPORATION | 0037882991 | 00191506043216 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |