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

Lot Number 0008021667

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

Patient Problems Stroke/CVA (1770); Intracranial Hemorrhage (1891); Tachycardia (2095); Visual Disturbances (2140); Shaking/Tremors (2515)

Event Date 01/13/2024

Event Type  Injury  

Event Description

Pf114 faradise clinical study, subject id: (b)(6).It was reported that after an irreversible electroporation ablation procedure using a farawave catheter the patient experienced a hemorrhagic stroke.The ablation procedure was completed on (b)(6) 2023.On (b)(6) 2024 the patient presented with visual disturbances and a cerebral mri was taken.An occipital stroke with a hemorrhagic component was identified.The patient was admitted to the hospital and ct scans were also performed.Their anticoagulant treatment was discontinued, the patient was given keppra and levetiracetam, and they were started on an antihypertensive treatment.The patient also experiences episodes of tachycardia and when these episodes finish, they experience tremors.The patient was discharged on (b)(6) 2024.The catheter is not expected to be returned as the complication emerged after the procedure, when the catheter would have been discarded.

Manufacturer Narrative

The device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, 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: 18758827
• MDR Text Key: 336004497
• Report Number: 2124215-2024-10522
• Device Sequence Number: 1
• Product Code: QZI
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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
• Device Lot Number: 0008021667
• 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
• Date Device Manufactured: 10/25/2023
• 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
• Patient Age: 71 YR
• Patient Sex: Female
• Patient Weight: 58 KG