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

Lot Number CL12031

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Arrhythmia (1721); Non specific EKG/ECG Changes (1817); Low Blood Pressure/ Hypotension (1914); Pain (1994); Convulsion/Seizure (4406)

Event Date 03/14/2024

Event Type  Injury  

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 at the end of an irreversible electroporation ablation procedure using a faradrive sheath the patient experienced st elevation and a seizure.The exact cause is currently unknown.A coronary angiography was performed in the ep suite and then the patient underwent a computed tomography (ct) brain scan.The patient was admitted to the hospital and the issue is considered on going.The ablation procedure was completed prior to interventions required for the patient.The sheath is not expected to be returned as it was discarded by the site.

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 at the end of an irreversible electroporation ablation procedure using a faradrive sheath the patient experienced st elevation and a seizure.The exact cause is currently unknown.A coronary angiography was performed in the ep suite and then the patient underwent a ct brain scan.The patient was admitted to the hospital and the issue is considered on going.The procedure was completed prior to interventions required for the patient.The sheath is not expected to be returned as it was discarded by the site.It was further reported that the performed coronary angiography did not produce any new findings.The physician no suspects the cause was an anaphylaxis to an unknown stimulus.The patient fully recovered within twelve hours of the incident and is in a stable condition.

• 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: 18952225
• MDR Text Key: 338267504
• Report Number: 2124215-2024-17248
• 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: 03/21/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/21/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Lot Number: CL12031
• 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: 07/28/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Hospitalization