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

Lot Number 0008021198

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

Patient Problem Respiratory Failure (2484)

Event Date 01/24/2024

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 a procedure using a farawave pulsed field ablation catheter the patient experienced respiratory failure.The procedure was performed without intubation, but there was evidence the patient had hypercapnic acidosis which required intubation for airway management.The procedure was completed successfully.Afterwards the patient was hospitalized in the intensive care unit.The respiratory failure was considered resolved with sequelae the next day.The device is not expected to be returned for analysis.Clinical study name: (b)(6) clinical study id: (b)(6) clinical patient id: (b)(6).

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

Clinical study name: (b)(6).Clinical study id: (b)(6).Clinical patient id: (b)(6).It was reported that at the end of a procedure using a farawave pulsed field ablation catheter the patient experienced respiratory failure.The procedure was performed without intubation, but there was evidence the patient had hypercapnic acidosis which required intubation for airway management.The procedure was completed successfully.Afterwards the patient was hospitalized in the intensive care unit.The respiratory failure was considered resolved with sequelae the next day.The device is not expected to be returned for analysis.It was further reported that the patient was administered an infusion of inotropic drugs as part of treatment.Laboratory blood tests and an x-ray scan were also performed for diagnostic purposes.

• 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 H4E 1 A2; CA H4E 1A2
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; dc a330; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 18794480
• MDR Text Key: 336397709
• Report Number: 2124215-2024-07263
• Device Sequence Number: 1
• Product Code: QZI
• Combination Product (y/n): N
• Reporter Country Code: IT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Study,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/07/2024

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: 0008021198
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/02/2024
• Initial Date FDA Received: 02/27/2024
• Supplement Dates Manufacturer Received: 02/28/2024
• Supplement Dates FDA Received: 03/07/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/26/2023
• 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; Hospitalization; Life Threatening
• Patient Age: 69 YR
• Patient Sex: Male
• Patient Weight: 80 KG