MAUDE Adverse Event Report: FARAPULSE, INC. / BOSTON SCIENTIFIC CORPORATION FARAPULSE PFA ABLATION SYSTEM FARAWAVE; PERCUTANEOUS CARDIAC ABLATION CATHETER FOR TREATMENT OF ATRIAL FIBRILLATION WITH

Patient Problem Necrosis (1971)

Event Date 03/19/2024

Event Type  Injury  

Event Description

Hemodialysis due to heme-related acute tubular necrosis after pulsed field ablation for atrial fibrillation.

• Brand Name: FARAPULSE PFA ABLATION SYSTEM FARAWAVE
• Type of Device: PERCUTANEOUS CARDIAC ABLATION CATHETER FOR TREATMENT OF ATRIAL FIBRILLATION WITH
• Manufacturer (Section D): FARAPULSE, INC. / BOSTON SCIENTIFIC CORPORATION
• MDR Report Key: 18960393
• MDR Text Key: 338489374
• Report Number: MW5153063
• Device Sequence Number: 1
• Product Code: QZI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/19/2024

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: Not provided
• Initial Date FDA Received: 03/21/2024
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Hospitalization; Life Threatening