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

Lot Number	CL15362
Medical Device Problem Code	Air/Gas in Device (4062)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/27/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the sheath exhibited air bubbles in the irrigation tubing during aspiration.During a pulse field ablation (pfa) procedure to treat paroxysmal atrial fibrillation a faradrive sheath was used.After insertion and introduction of the farawave catheter into the sheath aspiration was performed.Air bubbles were observed in the irrigation tubing.The sheath was replaced and the procedure was completed.No patient complications 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.

• Brand Name: FARADRIVE
• 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: 50817425
• Report Number: 2124215-2026-49898
• Device Sequence Number: 16005036
• Product Code: DRA
• UDI-Device Identifier: 00191506043131
• UDI-Public: (01)00191506043131(17)280217(10)CL15362
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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): 09/18/2026

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 Lot Number: CL15362
• 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: 08/27/2026
• Initial Report FDA Received Date: 09/18/2026
• Date Device Manufactured: 02/17/2026
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 57 YR
• Patient Sex: Male