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 Bradycardia (1751); Low Blood Pressure/ Hypotension (1914); Vomiting (2144)

Event Date 02/01/2024

Event Type  Injury  

Event Description

It was reported that during an irreversible electroporation ablation procedure using a farawave catheter the patient became hypotonic and bradycardic after vomiting.The patient vomited during the procedure, so a bronchoscopy was performed to ensure the vomited had not been aspirated.During the bronchoscopy the patient became "very hypotonic and bradycardic" so cpr was performed even though the patient did not flatline.It was noted the patient looked "very puffed up" when their covering was removed for resuscitation.Once the patient had sufficient rhythm without assistance they were intubated.A ct scan was performed and then the patient was moved to the intensive care unit for recovery.The ablation procedure was not completed, and no further complications have been reported.The catheter is not expected to be returned as it was disposed of by the hospital.

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.

• 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: 18679947
• MDR Text Key: 335070436
• Report Number: 2124215-2024-07565
• 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: 02/09/2024

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: 02/01/2024
• Initial Date FDA Received: 02/09/2024
• 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; Hospitalization; Life Threatening