FARADRIVE STEERABLE SHEATH CLEAR
Report
- Report Number
- 2124215-2025-78659
- Event Type
- Injury
- Date Received
- November 4, 2025
- Date of Event
- June 24, 2025
- Report Date
- December 2, 2025
- Manufacturer
- BOSTON SCIENTIFIC CORPORATION
- Product Code
- DRA
- UDI-DI
- 00191506043131
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
B5: DESCRIBE EVENT OR PROBLEM - UPDATED.
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.
DURING AN ATRIAL FIBRILLATION ABLATION PROCEDURE, A FARADRIVE STEERABLE SHEATH CLEAR WAS SELECTED FOR USE. APPROXIMATELY TEN MINUTES FOLLOWING DISCHARGE, THE PATIENT EXPERIENCED MODERATE BLEEDING DUE TO REOPENING OF THE LEFT GROIN ACCESS SITE. THE PATIENT PRESENTED TO MSM EMERGENCY DEPARTMENT AND WAS DISCHARGED WITH A HEMOSTATIC WOUND AND NO SIGNS OF HEMATOMA. THE DEVICE IS NOT EXPECTED TO BE RETURN DUE TO DISPOSAL. ADDITIONAL INFORMATION REVEALED THE PATIENT EXPERIENCED A SMALL GROIN BLEED AND IT RESOLVED SPONTANEOUSLY WITHOUT ANY MEDICAL INTERVENTION
DURING AN ATRIAL FIBRILLATION ABLATION PROCEDURE, A FARADRIVE STEERABLE SHEATH CLEAR WAS SELECTED FOR USE. APPROXIMATELY TEN MINUTES FOLLOWING DISCHARGE, THE PATIENT EXPERIENCED MODERATE BLEEDING DUE TO REOPENING OF THE LEFT GROIN ACCESS SITE. THE PATIENT PRESENTED TO MSM EMERGENCY DEPARTMENT AND WAS DISCHARGED WITH A HEMOSTATIC WOUND AND NO SIGNS OF HEMATOMA. THE DEVICE IS NOT EXPECTED TO BE RETURN DUE TO DISPOSAL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1841958 | FARADRIVE STEERABLE SHEATH CLEAR | VASCULAR GUIDE-CATHETER, SINGLE-USE | DRA | BOSTON SCIENTIFIC CORPORATION | CL13992 | 00191506043131 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 68 YR | Female | Other |