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

Lot Number CL12089

Device Problem Air/Gas in Device (4062)

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

Event Date 01/17/2024

Event Type  malfunction  

Manufacturer Narrative

Initial reporter phone: (b)(6).Visual inspection revealed no outer abnormalities.During preparation for leak testing, an attempt to purge the sheath of air/bubbles was unsuccessful.Air was continuously seen in the sheath shaft, and leaking was already observed near the side port.The device was examined on the microscope to locate the source of the leak path.Dissection of the sheath cap revealed that the flush lumen was torn close to the side port, where the adhesive filet bonds the lumen to the hub of the sheath.Subsequently, the valves were inspected using microscopy.No significant damage or deformation was observed.The complaint was confirmed through analysis.

Event Description

Reportable based on analysis completed on 11mar2024.It was reported that a faradrive steerable sheath clear during preparation presented an issue related to a leak.One of the physicians commented that probably the valve did not have the problem and could be related to the way the sheath was glued to the shaft.To solve the issue the sheath was replaced, and the procedure was completed without patient complications.It was further reported that there was no damage to the luer.The pump was in use.Dilator was wiped with saline prior to introduction into the valve.No tool or device was in place when the leak occurred.Dilator had been previously placed across the valve.No fluid leaking.The sheath leaked air, no air present in the patient.No insertion of farawave.The device has been returned for analysis.However, analysis of the returned device revealed a tear in the flush lumen close to the side port, where the adhesive filet bonds the lumen to the hub of the sheath.

• 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: 19006167
• MDR Text Key: 339099784
• Report Number: 2124215-2024-18121
• Device Sequence Number: 1
• Product Code: DRA
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 03/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: CL12089
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/08/2024
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/11/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/07/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1