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

Lot Number	CL15398
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Non specific EKG/ECG Changes (1817)
Date of Event	07/15/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It is reported that a st segment elevation occurred.During an atrial fibrillation procedure, a faradrive steerable sheath (clear) was selected.After going transseptal with a versacross device, physician went in with the mapping catheter, while mapping noticed st elevations, physician pulled everything out and referred to interventional cardiology for cardiac catheterization.Physician stated that this patient must have coronary disease and that is what caused the st elevation.Patient was kept overnight for observation and discharged the next day.Procedure was incomplete (aborted due to st elevation).

• 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: 50694249
• Report Number: 2124215-2026-48191
• Device Sequence Number: 9614308
• Product Code: DRA
• UDI-Device Identifier: 00191506043131
• UDI-Public: (01)00191506043131(17)280219(10)CL15398
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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): 09/09/2026

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: CL15398
• 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: 07/15/2026
• Initial Report FDA Received Date: 09/09/2026
• Date Device Manufactured: 02/19/2026
• 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; Hospitalization
• Patient Sex: Unknown