MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION DREAMWIRE; STYLET FOR CATHETER, GASTRO-UROLOGY

Model Number	M00556140
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/23/2025
Type of Reportable Event	Malfunction
Event or Problem Description
From staff: long wire would not advance in dreamtome; dreamtome broke at tip of end.

• Brand Name: DREAMWIRE
• Common Device Name: STYLET FOR CATHETER, GASTRO-UROLOGY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 23582055
• Report Number: 23582055
• Device Sequence Number: 9532687
• Product Code: EZB
• UDI-Device Identifier: 08714729779582
• UDI-Public: (01)08714729779582
• Combination Product (Y/N): N
• Initial Reporter State: ME
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/30/2025
• Report Date (Section F): 10/30/2025

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: M00556140
• Device Catalogue Number: M00556140
• Device Lot Number: 33668952
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 11/18/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/18/2025
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Age: 64 YR
• Patient Sex: Male
• Patient Weight: 86 KG
• Date Report Sent to FDA: 10/30/2025