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

Lot Number 0008021026

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

Patient Problems Non specific EKG/ECG Changes (1817); Vasoconstriction (2126)

Event Date 09/05/2023

Event Type  Injury  

Event Description

Clinical study name: faradise.Clinical study id: (b)(6).Patient id: (b)(6).It was reported after a procedure using a farawave pulsed field ablation catheter the patient experienced st segment elevation from a coronary spasm.The patient was hospitalized and a coronary angiogram was conducted.No lesions were observed.The st segment elevation reversed spontaneously two days later and the patient was discharged.The device is not expected to be returned for analysis.

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) patient id: (b)(6).It was reported after a procedure using a farawave pulsed field ablation catheter the patient experienced st segment elevation from a coronary spasm.The patient was hospitalized and a coronary angiogram was conducted.No lesions were observed.The st segment elevation reversed spontaneously two days later and the patient was discharged.The device is not expected to be returned for analysis.Coronary spasm was not confirmed by the angiography and was only suspected.

Manufacturer Narrative

Correction to the previously reported bsc aware date from (b)(6) 2023 to (b)(6)2024 as the event became reportable based on additional information that the patient was hospitalized received on (b)(6) 2024.Correction to previously reported h6 patient codes.The code e0516 vasoconstriction was removed as that complication was only speculated and not clinically confirmed.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: faradise, clinical study id: (b)(6).It was reported after a procedure using a farawave pulsed field ablation catheter the patient experienced st segment elevation from a coronary spasm.The patient was hospitalized and a coronary angiogram was conducted.No lesions were observed.The st segment elevation reversed spontaneously two days later and the patient was discharged.The device is not expected to be returned for analysis.

Manufacturer Narrative

Correction to the previously reported bsc aware date from 28-dec-2023 to 19-feb-2024 as the event became reportable based on additional information that the patient was hospitalized received on 19-feb-2024.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 H4E 1 A2; CA H4E 1A2
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; dc a330; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 18810618
• MDR Text Key: 336588361
• Report Number: 2124215-2024-12283
• Device Sequence Number: 1
• Product Code: QZI
• Combination Product (y/n): N
• Reporter Country Code: SP
• 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,Followup
• Report Date: 04/18/2024

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: 0008021026
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/28/2023
• Initial Date FDA Received: 02/29/2024
• Supplement Dates Manufacturer Received: 02/19/2024; 03/29/2024
• Supplement Dates FDA Received: 03/01/2024; 04/18/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/15/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 67 YR
• Patient Sex: Female
• Patient Weight: 65 KG