FARADRIVE STEERABLE SHEATH CLEAR
Report
- Report Number
- 2124215-2024-56722
- Event Type
- Malfunction
- Date Received
- September 11, 2024
- Date of Event
- September 1, 2024
- Report Date
- November 8, 2024
- Manufacturer
- FARAPULSE, INC.
- Product Code
- DRA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
THE DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS. UPON RECEIPT AND COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.
THE DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS. UPON RECEIPT AND COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.
IT WAS REPORTED THAT DURING A PULSED FIELD ABLATION (PFA) PROCEDURE A FARADRIVE STEERABLE SHEATH CLEAR WAS SELECTED FOR USE. WHEN THE PHYSICIAN INSERTED THE CATHETER INTO THE SHEATH, A LOT OF AIR BUBBLES WERE SUCKED OUT. THE PHYSICIAN DECIDED TO COMPLETE THE PROCEDURE WITH THE SAME DEVICE CAREFULLY. NO PATIENT COMPLICATIONS WERE REPORTED. THE DEVICE IS EXPECTED TO RETURN FOR LABORATORY ANALYSIS.
IT WAS REPORTED THAT DURING A PULSED FIELD ABLATION (PFA) PROCEDURE A FARADRIVE STEERABLE SHEATH CLEAR WAS SELECTED FOR USE. WHEN THE PHYSICIAN INSERTED THE CATHETER INTO THE SHEATH, A LOT OF AIR BUBBLES WERE SUCKED OUT. THE PHYSICIAN DECIDED TO COMPLETE THE PROCEDURE WITH THE SAME DEVICE CAREFULLY. NO PATIENT COMPLICATIONS WERE REPORTED. THE DEVICE IS NO LONGER EXPECTED TO RETURN FOR LABORATORY ANALYSIS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2020593 | FARADRIVE STEERABLE SHEATH CLEAR | CATHETER, STEERABLE | DRA | FARAPULSE, INC. | CL12889 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |