MAUDE Adverse Event Report: FARAPULSE, INC. FARADRIVE STEERABLE SHEATH CLEAR; CARDIAC IRREVERSIBLE ELECTROPORATION SYSTEM CATHETER

Lot Number CL11904

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

Patient Problem Pain (1994)

Event Date 12/06/2023

Event Type  Injury  

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.

Event Description

Faradise clinical study pf114 subject id: (b)(6).An index ablation procedure was completed on 28aug2024.Following a repeat pulse field ablation (pfa) procedure with a farawave catheter was performed on (b)(6) 2024.The following day, the patient experienced low back pain and was diagnoses by the general practitioner with a lumbago.As treatment celecoxib 200 mg and paracetamol were prescribed.The case is now reported as resolved.The related devices to the procedure will not be returned.

Manufacturer Narrative

Based upon analysis of all available information, bsc's investigation found no evidence to indicate that the pain was related to product performance of the faradrive sheath.There was no report of any device performance concerns.Investigators examined the details provided in the event description and found that the patient was diagnosed with lumbago.Therefore, it was determined that the most likely cause of the chest pain was an adverse event related to patient condition.

Event Description

Faradise clinical study (b)(6) subject id: (b)(6).An index ablation procedure was completed on (b)(6) 2024.Following a repeat pulse field ablation (pfa) procedure with a farawave catheter was performed on (b)(6) 2024.The following day, the patient experienced low back pain and was diagnoses by the general practitioner with a lumbago.As treatment celecoxib 200 mg and paracetamol were prescribed.The case is now reported as resolved.The related devices to the procedure will not be returned.

• Brand Name: FARADRIVE STEERABLE SHEATH CLEAR
• Type of Device: CARDIAC IRREVERSIBLE ELECTROPORATION SYSTEM CATHETER
• 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: angela hinkley ; 4100 hamline avenue north; dc a330; saint paul, MN 55112 ; 6514400979
• MDR Report Key: 18859658
• MDR Text Key: 337184071
• Report Number: 2124215-2024-14112
• Device Sequence Number: 1
• Product Code: QZI
• 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,Study
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/14/2024
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Lot Number: CL11904
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/28/2024
• Initial Date FDA Received: 03/07/2024
• Supplement Dates Manufacturer Received: 07/30/2024
• Supplement Dates FDA Received: 08/14/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/17/2023
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 72 YR
• Patient Sex: Female
• Patient Weight: 67 KG