MAUDE Adverse Event Report: FARAPULSE, INC. FARADRIVE STEERABLE SHEATH CLEAR; VASCULAR GUIDE-CATHETER, SINGLE-USE

Lot Number CL11962

Device Problems Leak/Splash (1354); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/08/2024

Event Type  malfunction  

Event Description

Reportable based on analysis completed on 18mar2024.It was reported that during an atrial fibrillation procedure a faradrive steerable sheath was selected for use.After inserting the sheath in the left atrium, the dilator was removed and flushed was opened, but a leak from the valve was observed.The sheath was replaced and the procedure was completed successfully.No patient complications were reported.The device has been received at boston scientific post market laboratory.Analysis of the device found a tear in the flush lumen near to the side port.

Manufacturer Narrative

Faradrive steerable sheath clear was evaluated by boston scientific.Visual inspection noted that the device does not have visual defects.The sheath was leaked tested and failed all leak testing.The device was analyzed on microscope.No damage was observed on the valves, however, it was observed that the flush lumen was torn close to the side port.The reported "hemostatic valve leak" was not confirmed by the device analysis.The "cause traced to device design" was selected for the secondary finding if a flush lumen tear, as the investigation determined the tear most likely occurred during use and handling; there was no evidence to indicate that the event was due to a design or manufacturing-related issue.Although the faradrive steerable sheath continues to perform within anticipated risk levels as outlined in the device's risk documentation, boston scientific has initiated a corrective and preventive action (capa) investigation to further investigate faradrive steerable sheath leak/difficulty to flush events where kinks/tears were found in the flush tubing.The investigation determined that these events were caused by either adhesive blockage in the flush tube, kinking of the flush tube, and/or leaking due to a tear or separation between the flush tube and hub valve.The investigation identified two (2) root causes: (1) there was not a flow rate specification defined to ensure the flush tube was not blocked, occluded, or leaking; and (2) inadequate clearance and alignment between the valve hub, flush tubing, and sheath handle cap which can lead to misalignment/compression of these mating components, resulting in an occlusion and/or tear in this location.As a result of the investigation, an occlusion test was added to the manufacturing process to detect sheaths with occluded flush tubing prior to final packaging.The capa investigation is ongoing and boston scientific is working with the supplier to determine whether any additional solutions will be implemented.

• Brand Name: FARADRIVE STEERABLE SHEATH CLEAR
• Type of Device: VASCULAR GUIDE-CATHETER, SINGLE-USE
• Manufacturer (Section D): FARAPULSE, INC.; 3715 haven avenue; suite 110; menlo park CA 94025
• Manufacturer (Section G): CENTERPOINT SYSTEMS; 3338 parkway blvd; west valley city UT 84119
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; dc a330; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 19102549
• MDR Text Key: 340811696
• Report Number: 2124215-2024-20876
• Device Sequence Number: 1
• Product Code: DRA
• Combination Product (y/n): N
• Reporter Country Code: GR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/13/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/13/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: CL11962
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/09/2024
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/18/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/14/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1