FARADRIVE STEERABLE SHEATH CLEAR
Report
- Report Number
- 2124215-2025-88082
- Event Type
- Injury
- Date Received
- December 2, 2025
- Date of Event
- November 24, 2025
- Report Date
- December 29, 2025
- Manufacturer
- FARAPULSE, INC.
- Product Code
- DRA
- UDI-DI
- 00810087180072
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
E1 INITIAL REPORTER PHONE: (B)(6). 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. THIS PRODUCT IS NOT APPROVED IN THE UNITED STATES, HOWEVER, IT HAS BEEN ASSESSED AS REPORTABLE AS THERE IS A SIMILAR PRODUCT APPROVED IN THE UNITED STATES. WE ARE UNABLE TO PROVIDE THE UNIQUE IDENTIFIER (UDI) AND OTHER SPECIFIC PRODUCT INFORMATION RELATED TO UNITED STATES REGISTRATION AS THE SPECIFIC PRODUCT IS ONLY COMMERCIALLY AVAILABLE OUTSIDE OF THE UNITED STATES.
THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED WITH AN UPDATE TO SECTIONS: B5. DESCRIBE EVENT OR PROBLEM. H6. IMPACT CODES. E.1. INITIAL REPORTER PHONE: (B)(6). 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. THIS PRODUCT IS NOT APPROVED IN THE UNITED STATES, HOWEVER, IT HAS BEEN ASSESSED AS REPORTABLE AS THERE IS A SIMILAR PRODUCT APPROVED IN THE UNITED STATES. WE ARE UNABLE TO PROVIDE THE UNIQUE IDENTIFIER (UDI) AND OTHER SPECIFIC PRODUCT INFORMATION RELATED TO UNITED STATES REGISTRATION AS THE SPECIFIC PRODUCT IS ONLY COMMERCIALLY AVAILABLE OUTSIDE OF THE UNITED STATES.
IT WAS REPORTED VIA CLINICAL STUDY THAT HEMATOMA, PAIN, AND HOSPITALIZATION OCCURRED. A PULSE FIELD ABLATION (PFA) PROCEDURE FOR ATRIAL FIBRILLATION WAS PERFORMED USING A FARADRIVE STEERABLE SHEATH, VIKING DIAGNOSTIC CATHETER, VERSACROSS ACCESS SOLUTION KIT, AND FARAWAVE CATHETER. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. POST PROCEDURALLY A HEMATOMA AT THE FEMORAL ACCESS SITE OCCURRED. THE PATIENT RECEIVED UNSPECIFIED TREATMENT AND WAS DISCHARGED. FOLLOWING DISCHARGE FROM THE HOSPITAL, THE PATIENT EXPERIENCED SIGNIFICANT PAIN FROM THE FEMORAL ACCESS SITE AND THE HEMATOMA GREW IN SIZE AND WAS VERY FIRM. THE PATIENT WAS ADMITTED TO THE HOSPITAL ONE DAY POST INDEX PROCEDURE. AN ANGIOGRAM OF THE LOWER LIMBS AND LABORATORY BLOOD WORK WERE PERFORMED. THE PATIENT CONTINUES RECOVERY IN THE HOSPITAL.
IT WAS REPORTED VIA CLINICAL STUDY THAT HEMATOMA, PAIN, AND HOSPITALIZATION OCCURRED. A PULSE FIELD ABLATION (PFA) PROCEDURE FOR ATRIAL FIBRILLATION WAS PERFORMED USING A FARADRIVE STEERABLE SHEATH, VIKING DIAGNOSTIC CATHETER, VERSACROSS ACCESS SOLUTION KIT, AND FARAWAVE CATHETER. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. POST PROCEDURALLY A HEMATOMA AT THE FEMORAL ACCESS SITE OCCURRED. THE PATIENT RECEIVED UNSPECIFIED TREATMENT AND WAS DISCHARGED. FOLLOWING DISCHARGE FROM THE HOSPITAL, THE PATIENT EXPERIENCED SIGNIFICANT PAIN FROM THE FEMORAL ACCESS SITE AND THE HEMATOMA GREW IN SIZE AND WAS VERY FIRM. THE PATIENT WAS ADMITTED TO THE HOSPITAL ONE DAY POST INDEX PROCEDURE. AN ANGIOGRAM OF THE LOWER LIMBS AND LABORATORY BLOOD WORK WERE PERFORMED. THE PATIENT CONTINUES RECOVERY IN THE HOSPITAL. IT WAS FURTHER REPORTED THE PATIENT UNDERWENT MAGNETIC RESONANCE IMAGING AND ULTRASOUND OF THE ILIAC AND FEMORAL ARTERIES. THE PATIENT RECEIVED TWO (2) UNITS OF BLOOD AND AN INTRAARTERIAL INJECTION OF THROMBIN. THE PATIENT WAS DISCHARGED TWELVE (12) DAYS POST HOSPITAL ADMISSION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2809616 | FARADRIVE STEERABLE SHEATH CLEAR | CATHETER, STEERABLE | DRA | FARAPULSE, INC. | 00810087180072 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 76 YR | Female | Hospitalization |