MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION FARAPOINT Pulsed Field Ablation Catheter; Percutaneous Cardiac Ablation Catheter For Treatment Of Atrial Fibrillation With Irreversible Electroporation

Model Number	PF81M11
Medical Device Problem Code	Off-Label Use (1494)
Health Effect - Clinical Codes	Bradycardia (1751); Cardiac Arrest (1762); Low Blood Pressure/ Hypotension (1914); Pain (1994)
Date of Event	08/26/2026
Type of Reportable Event	Death
Event or Problem Description
It was reported that the patient experienced bradycardia, hypotension, and cardiac arrest after the procedure.The patient died.During a cavotricuspid isthmus (cti) ablation procedure to treat atrial flutter a farapoint catheter was used.Use of the farapoint catheter to treat atrial flutter constituted off-label use of the device per the instructions for use (ifu).Groin access was obtained under ultrasound guidance.The coronary sinus catheter and intracardiac echocardiography (ice) catheter were placed, then the farapoint catheter was inserted and advanced to the right atrium (ra).Mapping was performed with the farapoint catheter before it was positioned at the tv annulus to begin ablation.500mcg of intravenous (iv) nitroglycerin was administered prior to beginning ablation.Seventeen ablation applications were made under ice and 3d mapping guidance.There were no st segment changes observed on the 12-lead electrogram (ecg) while the procedure was ongoing.The procedure was completed and the patient was taken to the post anesthesia care unit (pacu) for recovery prior to being sent back to their inpatient room.Overnight the patient became bradycardic, hypotensive, and went into cardiac arrest.The patient was in normal sinus rhythm before their heart rate dropped into the 50's beats per minute (bpm), then into the 40's bpm with junctional escape, eventually into ventricular escape, and finally to cardiac arrest.Cardiopulmonary resuscitation (cpr) was attempted but the patient expired.Prior to the event the patient complained of groin and leg pain.No chest pain, tightness, or discomfort were reported.
Additional Manufacturer Narrative
It was indicated that the device will not be returned for evaluation.When any further relevant information is obtained, a supplemental medwatch will be filed.D2a: common device name: percutaneous cardiac ablation catheter for treatment of atrial fibrillation with irreversible electroporation; reported here as the common device name exceeded the character limit for designated field.Detailed product information was not provided to bsc.Good faith efforts to obtain the information are in progress.Because the product is unknown, we are unable to provide the unique identifier (udi) and other specific product information at this time.A supplemental report will be filed if the information is received.

• Brand Name: FARAPOINT Pulsed Field Ablation Catheter
• Common Device Name: Percutaneous Cardiac Ablation Catheter For Treatment Of Atrial Fibrillation With Irreversible Electroporation
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer Contact: mary crawford ; 4100 hamline avenue north; dc a330; saint paul, MN 55112 ; +1(651)440-0979
• MDR Report Key: 50818605
• Report Number: 2124215-2026-49936
• Device Sequence Number: 21371772
• Product Code: QZI
• UDI-Device Identifier: 00191506047207
• UDI-Public: (01)00191506047207
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/18/2026

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
• Operator of Device: Health Professional
• Device Model Number: PF81M11
• Device Catalogue Number: PF81M11
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/26/2026
• Initial Report FDA Received Date: 09/18/2026
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Death
• Patient Sex: Unknown