FARADRIVE STEERABLE SHEATH CLEAR
Report
- Report Number
- 2124215-2026-06674
- Event Type
- Injury
- Date Received
- February 5, 2026
- Date of Event
- December 23, 2025
- Report Date
- April 14, 2026
- Manufacturer
- BOSTON SCIENTIFIC CORPORATION
- Product Code
- DRA
- UDI-DI
- 00191506043131
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AR, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
GOOD FAITH EFFORT ATTEMPTS WERE MADE TO TRY AND RETRIEVE THE DEVICE STATUS, BUT IT WAS UNABLE TO BE OBTAINED. CORRECTION TO THE INITIAL, MDR IN BLOCK(S) B5, H10 DENOTING THE EVENT DUPLICATION.
GOOD FAITH EFFORT ATTEMPTS WERE MADE TO TRY AND RETRIEVE THE DEVICE STATUS, BUT IT WAS UNABLE TO BE OBTAINED. CORRECTION TO THE INITIAL, MDR IN BLOCK(S) B5, H10 DENOTING THE EVENT DUPLICATION INVESTIGATION SUMMARY: BASED ON THE AVAILABLE INFORMATION, ALTHOUGH THE PRODUCT WAS DISPOSED OF AND COULD NOT BE RETURNED, WE HAVE DETERMINED THAT THE CARDIAC TAMPONADE, HYPERTENSION, PLEURAL EFFUSION, AND CARDIAC PERFORATION ARE KNOWN INHERENT RISKS OF USE OF THIS DEVICE. DEVICE HISTORY RECORD REVIEW: THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY, AND PERFORMANCE SPECIFICATIONS. DEVICE TECHNICAL ANALYSIS: IT WAS INDICATED THE DEVICE IS UNAVAILABLE FOR RETURN; THEREFORE, A TECHNICAL ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. 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. RISK REVIEW: A RISK REVIEW PERFORMED FOR THE FARADRIVE DEVICE CONFIRMED THAT THE EVENTS OF CARDIAC TRAUMA AND HF/EDEMA ARE KNOWN EVENTS DEFINED IN THE PRODUCT RISK MANAGEMENT DOCUMENTATION. THIS EVENT TYPE HAS 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 FARADRIVE DEVICE IS ACCEPTABLE. INVESTIGATION CONCLUSION: BASED ON THE INFORMATION, THE CARDIAC TAMPONADE AND CARDIAC PERFORATION ARE CONSIDERED WITHIN THE RISK THRESHOLD OF CARDIAC TRAUMA AND PLEURAL EFFUSION IS CONSIDERED WITHIN THE RISK THRESHOLD OF HF/EDEMA. CARDIAC TRAUMA, HF/EDEMA, AND HYPERTENSION ARE EXPECTED PROCEDURAL COMPLICATIONS ADDRESSED WITHIN THE IFU FOR THE FARADRIVE SHEATH. THERE WERE NO ALLEGATIONS OF A QUALITY OR MANUFACTURING DEFICIENCY LEADING TO THE ADVERSE EVENT AS REPORTED TO BSC, AND THE DEVICE HAS NOT BEEN RETURNED FOR ANALYSIS AT THIS TIME.
GOOD FAITH EFFORT ATTEMPTS WERE MADE TO TRY AND RETRIEVE THE DEVICE STATUS, BUT IT WAS UNABLE TO BE OBTAINED.
IT WAS REPORTED THAT A PATIENT EXPERIENCED A CARDIAC TAMPONADE AND PLEURAL EFFUSION, ALSO THAT THE VERSACROSS WIRE PUNCTURED THE PATIENT'S LEFT ATRIUM ROOF. THE DEVICE WAS REMOVED, AND THE PROCEDURE WAS ABORTED. ALSO A FARADRIVE SHEATH PRESENTED A VALVE MALFUNCTION. SHORTLY AFTER CROSSING TRANSSEPTAL, PATIENT ACQUIRED A LARGE PERICARDIAL EFFUSION REQUIRING INTERVENTION DUE TO THREATENED TAMPONADE. PERICARDIAL DRAINS WERE PLACED. THE PATIENT RECEIVED SEVERAL UNITS OF PRBC PATIENT TO ADMIT TO ICU, 1.7 L OF BLOOD WAS REMOVED. PERICARDIAL DRAIN X 2 WAS INSERTED. PATIENT WAS INTUBATED/SEDATED PRIOR TO THIS. PATIENT, IN TOTAL, RECEIVED 5 UNITS PRBCS, 1 UNIT FFP, 1 UNIT PLATELET, KCENTRANORMOTENSIVE/BORDERLINE HYPERTENSIVE-- START CLEVIPREX/AS NEEDED HYDRALAZINE FOR HYPERTENSION. BILATERAL PLEURAL EFFUSIONS REQUIRED LEFT-SIDED THORACENTESIS. (B)(6) 2025 THE THORACENTESIS CATHETER WAS THEN THREADED WITHOUT DIFFICULTY. THE PATIENT HAD 400 CC OF SEROSANGUINEOUS REMOVED. THROUGHOUT ADMISSION PATIENT DID CONVERT TO ATRIAL FIBRILLATION, AMIODARONE-INITIATED GTT. HOWEVER, DID NOT CONVERT TO SINUS RHYTHM. AMIODARONE DISCONTINUED, TOPROL INITIATED 25 MG TWICE DAILY. PATIENT TO RESUME XARELTO ON (B)(6) 2025. PATIENT WAS ADMITTED ON (B)(6) 2025 AND DISCHARGED ON (B)(6) 2025. PER ADDITIONAL INFORMATION RECEIVED, ECHO- LVEF AROUND 60%, WHAT APPEARED TO BE CLOTTED BLOOD AROUND THE PERICARDIUM, NO ACTIVE PERICARDIAL EFFUSION. DAILY ECHOS ON (B)(6) 2026. CBC, CMP, BLOOD GASES. DAILY LABS WHILE ADMITTED (B)(6) 2025 -(B)(6) 2025. CHEST XRAYS DAILY - NO EVIDENCE OF ACUTE CARDIOPULMONARY PROCESS. - CHEST XRAYS DAILY (B)(6) 2025. CHEST ULTRASOUND-MINIMAL RIGHT PLEURAL EFFUSION. RIGHT PLEURAL EFFUSION VOLUME APPEARS INADEQUATE FOR THORACENTESIS. SMALL/MODERATE LEFT PLEURAL EFFUSION. 5 UNITS PRBCS, 1 UNIT FFP, 1 UNIT PLATELET, KCENTRA. PERICARDIOCENTESIS AND PERICARDOTOMY WERE REQUIRED.
IT WAS REPORTED THAT A PATIENT EXPERIENCED A CARDIAC TAMPONADE AND PLEURAL EFFUSION, ALSO THAT THE VERSACROSS WIRE PUNCTURED THE PATIENT'S LEFT ATRIUM ROOF. THE DEVICE WAS REMOVED, AND THE PROCEDURE WAS ABORTED. ALSO A FARADRIVE SHEATH PRESENTED A VALVE MALFUNCTION. SHORTLY AFTER CROSSING TRANSSEPTAL, PATIENT ACQUIRED A LARGE PERICARDIAL EFFUSION REQUIRING INTERVENTION DUE TO THREATENED TAMPONADE. PERICARDIAL DRAINS WERE PLACED. THE PATIENT RECEIVED SEVERAL UNITS OF PRBC PATIENT TO ADMIT TO ICU, 1.7 L OF BLOOD WAS REMOVED. PERICARDIAL DRAIN X 2 WAS INSERTED. PATIENT WAS INTUBATED/SEDATED PRIOR TO THIS. PATIENT, IN TOTAL, RECEIVED 5 UNITS PRBCS, 1 UNIT FFP, 1 UNIT PLATELET, KCENTRANORMOTENSIVE/BORDERLINE HYPERTENSIVE-- START CLEVIPREX/AS NEEDED HYDRALAZINE FOR HYPERTENSION. BILATERAL PLEURAL EFFUSIONS REQUIRED LEFT-SIDED THORACENTESIS.12/26/2025 THE THORACENTESIS CATHETER WAS THEN THREADED WITHOUT DIFFICULTY. THE PATIENT HAD 400 CC OF SEROSANGUINEOUS REMOVED. THROUGHOUT ADMISSION PATIENT DID CONVERT TO ATRIAL FIBRILLATION, AMIODARONE-INITIATED GTT. HOWEVER, DID NOT CONVERT TO SINUS RHYTHM. AMIODARONE DISCONTINUED, TOPROL INITIATED 25 MG TWICE DAILY. PATIENT TO RESUME XARELTO ON 12/31/2025. PATIENT WAS ADMITTED ON 23-DEC-2025 AND DISCHARGED ON 29-DEC-2025. PER ADDITIONAL INFORMATION RECEIVED, ECHO- LVEF AROUND 60%, WHAT APPEARED TO BE CLOTTED BLOOD AROUND THE PERICARDIUM, NO ACTIVE PERICARDIAL EFFUSION. DAILY ECHOS ON 12/23, 12/24, 12/25/2026. CBC, CMP, BLOOD GASES. DAILY LABS WHILE ADMITTED 12/23/25 -12/29/25. CHEST XRAYS DAILY - NO EVIDENCE OF ACUTE CARDIOPULMONARY PROCESS. - CHEST XRAYS DAILY 12/23-12/28/2025. CHEST ULTRASOUND-MINIMAL RIGHT PLEURAL EFFUSION. RIGHT PLEURAL EFFUSION VOLUME APPEARS INADEQUATE FOR THORACENTESIS. SMALL/MODERATE LEFT PLEURAL EFFUSION. 5 UNITS PRBCS, 1 UNIT FFP, 1 UNIT PLATELET, KCENTRA. PERICARDIOCENTESIS AND PERICARDOTOMY WERE REQUIRED.
IT WAS REPORTED THAT THE FARADRIVE SHEATH PUNCTURED THE PATIENT'S LEFT ATRIUM ROOF. THE DEVICE WAS REMOVED, AND THE PROCEDURE WAS ABORTED. THE PATIENT WAS REPORTED TO ALSO HAVE EXPERIENCED CARDIAC TAMPONADE WHICH REQUIRED UNEXPECTED MEDICAL TREATMENT INCLUDING PROLONGED HOSPITALIZATION WITH INTENSIVE CARE AND A BLOOD TRANSFUSION. IT IS UNKNOWN IF THE DEVICE IS EXPECTED TO BE RETURNED FOR ANALYSIS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 333206 | FARADRIVE STEERABLE SHEATH CLEAR | CATHETER, STEERABLE | DRA | BOSTON SCIENTIFIC CORPORATION | CL14712 | 00191506043131 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 74 YR | Female | Required Intervention| H |