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

Lot Number CL12230

Device Problems Leak/Splash (1354); Device Contamination with Body Fluid (2317)

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

Event Date 02/06/2024

Event Type  malfunction  

Event Description

It was reported that a faradrive steerable sheath clear during procedure for an atrial fibrillation blood was noticed flowing from the valve of the sheath, the valve was not hermetic.This happened after the physician performed the transseptal puncture with the sheath, he removed the dilator and did the purge of the material, then connected the irrigation, but a few seconds after blood was noticed.To solve the issue, the sheath was replaced because there was a risk of air introduction in the patient.Then the procedure was completed without patient complications.Device return status is unknown.

Manufacturer Narrative

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.

• 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: 18818495
• MDR Text Key: 336884996
• Report Number: 2124215-2024-11625
• Device Sequence Number: 1
• Product Code: DRA
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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: 03/01/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/01/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: CL12230
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/06/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/30/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1