MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION FARADRIVE Steerable Sheath Clear; Catheter, Steerable

Lot Number	CL15476
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Atrial Flutter (1730); Low Blood Pressure/ Hypotension (1914); Pericardial Effusion (3271)
Date of Event	09/01/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that pericardial effusion occurred.Faradrive steerable sheath was selected for use during farapulse pulsed field ablation.It has been mentioned that patient arrived in flutter during an atrial fibrillation ablation under deep sedation.The ice catheter was introduced into right atrium and then right ventricle and scanned noting a baseline effusion around the basal aspect of the right ventricle.Transeptal was performed without issue noted and visualized under ice.The ice catheter was introduced into the left atrium.A decapolar coronary sinus catheter was then placed into the coronary sinus.An eccentric activation pattern was noted and suspected roof dependent flutter.All 4 veins were isolated and the flutter persisted.A posterior wall isolation was performed.Termination occurred during an application in flower.Pressure dropped following conversion and anesthesia noted they were not responding to pressors.The farapulse catheter and faradrive sheath were removed from the la.Ice was then pulled back to the right atrium and scanned the pericardium.An increase in the pericardial effusion was noted to approximately 1cm.Hepranization was reversed and anesthesia supported pressures.The effusion was monitored under transthoracic echo and noted no change in effusion size over 30min.Echo contrast was administered and assessed if it enter the pericardial space and it was noted that no contrast had entered the space.Over time with reversal of anesthetic hemodynamics returned to baseline and it was determined that the effusion was to small to tap.The patient was admitted for overnight observation and is expected to make a full recovery.The physician does not believe any boston scientific product was responsible for the small effusion.The patient is expected to be discharged next day with no adverse outcomes.Baseline effusion was noted with ice as the first catheter in the right atrium.The increase from 3-5mm to approximately 1 cm was identified after pulmonary vein isolation and posterior wall ablation when everything was removed from the left atrium.The patient is in stable condition.

• Brand Name: FARADRIVE Steerable Sheath Clear
• Common Device Name: Catheter, Steerable
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): CENTERPOINT SYSTEMS; 3338 parkway blvd; west valley city UT 84119
• Manufacturer Contact: mary crawford ; 4100 hamline avenue north; dc a330; saint paul, MN 55112 ; +1(651)440-0979
• MDR Report Key: 50803247
• Report Number: 2124215-2026-49666
• Device Sequence Number: 10544438
• Product Code: DRA
• UDI-Device Identifier: 00191506043131
• UDI-Public: (01)00191506043131(17)280305(10)CL15476
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/17/2026

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 Lot Number: CL15476
• 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: 09/01/2026
• Initial Report FDA Received Date: 09/17/2026
• Date Device Manufactured: 03/05/2026
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Sex: Unknown