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

Lot Number CL12292

Device Problem Leak/Splash (1354)

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

Event Date 03/29/2024

Event Type  malfunction  

Event Description

It was reported that a faradrive steerable sheath clear during insertion for a pulmonary vein isolation procedure to treat an atrial flutter, presented a leak issue.First the sheath was taken out from its package and prepared per the recommended guidelines (flush the flush port & guidewire lumen with a 20cc syringe).Afterwards, the dilator was flushed and inserted into the sheath.The transseptal puncture was performed with the faradrive sheath.After going transseptal, the dilator was removed, and the sheath was aspirated per guidelines.That's when the physician noticed that the hemostatic valve was leaking, then we the leak concluded, it was decided to switch out the sheath for another one.The new one did not have a leak and the procedure was successfully completed without patient complications.The device is expected to be returned.It was further reported that the luer was not damaged.The sheath had not been connected to the flush yet as the physician spotted the leak when aspirating.Prior to the leak a dilator and a non-boston scientific transseptal needle were inside the sheath.The sheath was slowly dripping blood from the valve.I'm not aware of any air leaks.No air was seen in the patient.

• 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: 19074034
• MDR Text Key: 339787246
• Report Number: 2124215-2024-21577
• Device Sequence Number: 1
• Product Code: DRA
• Combination Product (y/n): N
• Reporter Country Code: BE
• 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: 04/09/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/09/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: CL12292
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/29/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/07/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1