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

Lot Number CL12136

Device Problem Air/Gas in Device (4062)

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

Event Date 03/14/2024

Event Type  malfunction  

Manufacturer Narrative

It was indicated that the device will not be returned for evaluation.If there is any further relevant information obtained, a supplemental medwatch will be filed.

Event Description

It was reported that during procedure a faradrive steerable sheath was selected for use, however after the faradrive sheath was introduced to the patient after transseptal puncture and the dilator was removed along while wire was kept inside, the physician started aspirate through the faradrive sheath but air bubbles kept getting out of the device handle and into the three-way stopcock/syringe, therefore it was decided to replace the device and the issue was resolved.The procedure was completed.No patient complications were reported.The device is not expected to be returned; it was disposed at facility.

• 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: 19035758
• MDR Text Key: 339286582
• Report Number: 2124215-2024-20325
• Device Sequence Number: 1
• Product Code: DRA
• Combination Product (y/n): N
• Reporter Country Code: AS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/03/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/03/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: CL12136
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/14/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/10/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1