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

Lot Number CL11987

Device Problems Suction Problem (2170); Air/Gas in Device (4062)

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

Event Date 12/19/2023

Event Type  malfunction  

Manufacturer Narrative

Visual inspection revealed that the sheath was returned and went through sterilization with a dilator still inserted.The sheath was leak tested and the device failed the 15 psi positive pressure test in empty condition.The valves were inspected using microscopy.It was noted that the valves were not sealing properly, which is likely due to the dilator being inserted in the sheath for an extended period of time during storage/shipping.

Event Description

Reportable based on analysis completed on 05mar2024.It was reported that a faradrive steerable sheath clear during procedure, a lot of bubbles were aspirated.It was suspected that the valve was not working properly.To solve the issue the sheath was replaced, and the procedure completed without patient complications.The device has been returned.However, returned device analysis also revealed a leak in the sheath valve.

• 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: 18851150
• MDR Text Key: 337183974
• Report Number: 2124215-2024-13578
• Device Sequence Number: 1
• Product Code: DRA
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/06/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/06/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: CL11987
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/25/2024
• Date Manufacturer Received: 03/05/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/13/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1