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

Lot Number CL12135

Device Problem Difficult to Advance (2920)

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

Event Date 02/28/2024

Event Type  malfunction  

Event Description

It was reported that during an irreversible electroporation ablation procedure using a fararive sheath the sheath was difficult to advance into the left atrium.The dilator easily crossed the septum, however, it was difficult to advance the sheath itself through the puncture.The physician is unsure if it was a poor puncture or if the tapering of the dilator into the sheath caused the difficulty.Another puncture was performed but the sheath still would not access the left atrium.The procedure was cancelled at that time with no patient complications.The sheath is expected to be returned for analysis.This event is being reported for aborted/cancelled procedure with a patient under sedation.

Manufacturer Narrative

The returned sheath was analyzed, passed all tests performed, and exhibited normal device characteristics.The reported event was not confirmed.No problem was detected with the returned device that could have caused or contributed to the issues advancing the sheath seen in the field, nor were any other types of defects identified during the investigation.Ultimately the cause of the difficulty to advance the sheath could not be determined.

Event Description

It was reported that during an irreversible electroporation ablation procedure using a fararive sheath the sheath was difficult to advance into the left atrium.The dilator easily crossed the septum; however, it was difficult to advance the sheath itself through the puncture.The physician is unsure if it was a poor puncture or if the tapering of the dilator into the sheath caused the difficulty.Another puncture was performed but the sheath still would not access the left atrium.The procedure was cancelled at that time with no patient complications.The sheath has been returned for analysis.

• 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: 18934219
• MDR Text Key: 338070256
• Report Number: 2124215-2024-16344
• 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,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/19/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: CL12135
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/18/2024
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/28/2024
• Initial Date FDA Received: 03/19/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/27/2023
• 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