MAUDE Adverse Event Report: FARAPULSE, INC. FARAWAVE PULSED FIELD ABLATION CATHETER; CARDIAC IRREVERSIBLE ELECTROPORATION SYSTEM CATHETER

Lot Number 0032380696

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

Patient Problems Cognitive Changes (2551); Respiratory Insufficiency (4462)

Event Date 03/21/2024

Event Type  Injury  

Manufacturer Narrative

Initial reporter phone number exceeded max character limit: (b)(6).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 a pulse field ablation (pfa) procedure using a farawave pulsed field ablation catheter the patient experienced low oxygen saturation due to sedation for the procedure.The procedure was cancelled due to the general condition of the patient and he/she was admitted to the intensive care unit.Cognitive limitations were also observed.The patient couldn't answer questions from the physician accurately, though this may have been due to deep sedation and a language barrier.A computed tomography (ct) scan was performed with no findings.The critical situation normalized after an hour and the patient condition was considered stable.No cognitive limitations were noted after the event.The device is not expected to be returned for analysis due to disposal.

• Brand Name: FARAWAVE PULSED FIELD ABLATION CATHETER
• 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): BOSTON SCIENTIFIC CORPORATION; 302 parkway, global park; la aurora - heredia ; CS
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; dc a330; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 19103286
• MDR Text Key: 340106441
• Report Number: 2124215-2024-22479
• Device Sequence Number: 1
• Product Code: QZI
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 04/15/2024

1 Device was Involved in the Event

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: 0032380696
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/21/2024
• Initial Date FDA Received: 04/15/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/08/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Hospitalization; Life Threatening