MAUDE Adverse Event Report: FARAPULSE, INC. FARAWAVE PULSED FIELD ABLATION CATHETER, 31MM; CARDIAC IRREVERSIBLE ELECTROPORATION SYSTEM CATHETER

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

Patient Problems Low Blood Pressure/ Hypotension (1914); Cardiac Tamponade (2226)

Event Date 02/15/2024

Event Type  Injury  

Event Description

It was reported that after an irreversible electroporation ablation procedure using a farawave catheter the patient developed cardiac tamponade.During the procedure the patient had "hemodynamic instabilities", but the procedure was completed successfully.During recovery, prior to discharge, tamponade was identified after the patient's blood pressure dropped.An echocardiography was taken, and the tamponade was identified.Drainage was performed and the patient is stable.No further complications have been reported.The catheter is not expected to be returned as the complication emerged after the procedure, when the catheter would have been discarded.

Manufacturer Narrative

Initial reporter phone: (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.

• Brand Name: FARAWAVE PULSED FIELD ABLATION CATHETER, 31MM
• 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): AGILE MV INC; 3700 st patrick st; suite 102; montreal, qc ; CA
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; dc a330; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 18759601
• MDR Text Key: 336052040
• Report Number: 2124215-2024-10526
• 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: 02/22/2024

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/15/2024
• Initial Date FDA Received: 02/22/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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