FARADRIVE
Report
- Report Number
- 2124215-2025-17642
- Event Type
- Injury
- Date Received
- March 24, 2025
- Date of Event
- February 28, 2025
- Report Date
- June 30, 2025
- Manufacturer
- BOSTON SCIENTIFIC CORPORATION
- Product Code
- DRA
- UDI-DI
- 00191506043131
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
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. UPDATED FIELD B5 WITH NEW INFORMATION OBTAINED. H6 FIELD UPDATED: PATIENT CODE E050301 AIR EMBOLISM CODE ADDED.
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.
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. UPDATED FIELD B5 WITH NEW INFORMATION OBTAINED. H6 FIELD UPDATED: PATIENT CODE E050301 AIR EMBOLISM CODE ADDED. UPDATED FIELD B5. CODE E0516 VASOCONSTRICTION REMOVED.
IT WAS REPORTED THAT A PATIENT EXPERIENCED A ST SEGMENT ELEVATION. DURING A PULSED FIELD ABLATION (PFA) PROCEDURE TO TREAT AN ATRIAL FIBRILLATION A FARADRIVE WAS SELECTED FOR USE. AFTER PERFORMING A CAVOTRICUSPID ISTHMUS (CTI) ABLATION, THE PATIENT HAD A SPASM AND ST ELEVATION OCCURRED. WHEN THE ISSUE OCCURRED, IT WAS NOTICED THAT AIR HAS APPEARED. A CORONARY ANGIOGRAM (CAG) WAS PERFORMED AND THE ST BECAME STABLE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THE DEVICE IS NOT EXPECTED TO RETURN AS IT WAS DISPOSED. IT WAS FURTHER REPORTED THAT ST ELEVATION OCCURRED WHEN THE CATHETER WAS EXCHANGED. IRRIGATION WAS NEVER INTERRUPTED. AIR WAS OBSERVED IN THE LEFT ATRIUM. THE PATIENT HAD FULLY RECOVERED FROM THE EVENT.
IT WAS REPORTED THAT A PATIENT EXPERIENCED A ST SEGMENT ELEVATION. DURING A PULSED FIELD ABLATION (PFA) PROCEDURE TO TREAT AN ATRIAL FIBRILLATION A FARADRIVE WAS SELECTED FOR USE. AFTER PERFORMING A CAVOTRICUSPID ISTHMUS (CTI) ABLATION, THE PATIENT HAD A SPASM AND ST ELEVATION OCCURRED. WHEN THE ISSUE OCCURRED, IT WAS NOTICED THAT AIR HAS APPEARED. A CORONARY ANGIOGRAM (CAG) WAS PERFORMED AND THE ST BECAME STABLE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THE DEVICE IS NOT EXPECTED TO RETURN AS IT WAS DISPOSED.
IT WAS REPORTED THAT A PATIENT EXPERIENCED A ST SEGMENT ELEVATION. DURING A PULSED FIELD ABLATION (PFA) PROCEDURE TO TREAT AN ATRIAL FIBRILLATION A FARADRIVE WAS SELECTED FOR USE. AFTER PERFORMING A CAVOTRICUSPID ISTHMUS (CTI) ABLATION, THE PATIENT HAD A SPASM AND ST ELEVATION OCCURRED. WHEN THE ISSUE OCCURRED, IT WAS NOTICED THAT AIR HAS APPEARED. A CORONARY ANGIOGRAM (CAG) WAS PERFORMED AND THE ST BECAME STABLE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THE DEVICE IS NOT EXPECTED TO RETURN AS IT WAS DISPOSED. IT WAS FURTHER REPORTED THAT ST ELEVATION OCCURRED WHEN THE CATHETER WAS EXCHANGED. IRRIGATION WAS NEVER INTERRUPTED. AIR WAS OBSERVED IN THE LEFT ATRIUM. THE PATIENT HAD FULLY RECOVERED FROM THE EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1131858 | FARADRIVE | VASCULAR GUIDE-CATHETER, SINGLE-USE | DRA | BOSTON SCIENTIFIC CORPORATION | CL13555 | 00191506043131 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Required Intervention |