MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION FARASTAR; PERCUTANEOUS CARDIAC ABLATION CATHETER FOR TREATMENT OF ATRIAL FIBRILLATION

Model Number	M004PF61M401
Medical Device Problem Codes	Off-Label Use (1494); Defective Device (2588)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/25/2024
Type of Reportable Event	Malfunction
Additional 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.
Event or Problem Description
It was reported that during a pulsed field ablation (pfa) procedure to treat a recurrent persistent atrial fibrillation (off-label use) a farastar pulsed field ablation system was selected for use.Recurrent 301 errors were displayed after the first two deliveries.No spline inversion was noticed on ice or fluoro.The deployment was successful; however, the system error restricted the energy delivery.The error persisted despite replacing the cable, catheter, sheath and restarting the generator.The procedure had to be cancelled as the physician was not prepared to switch to radiofrequency.The patient was already sedated when the procedure was cancelled.The device return for analysis is unknown.This event is being reported for aborted/cancelled procedure with a patient under sedation.

• Brand Name: FARASTAR
• Common Device Name: PERCUTANEOUS CARDIAC ABLATION CATHETER FOR TREATMENT OF ATRIAL FIBRILLATION
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer Contact: angela hinkley ; 4100 hamline avenue north; dc a330; saint paul, MN 55112 ; 6514400979
• MDR Report Key: 20687360
• Report Number: 2124215-2024-71669
• Device Sequence Number: 15618037
• Product Code: QZI
• UDI-Device Identifier: 00191506042882
• UDI-Public: 00191506042882
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P230030
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/14/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: M004PF61M401
• Device Catalogue Number: M004PF61M401
• 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: 10/25/2024
• Initial Report FDA Received Date: 11/14/2024
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown