MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION MAILMAN; WIRE, GUIDE, CATHETER

Model Number	2735
Medical Device Problem Codes	Difficult to Advance (2920); Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/22/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Good faith effort attempts were made to try and retrieve additional details regarding the reported event, but further information was unable to be obtained.
Event or Problem Description
It was reported that foreign material present on device occurred.The target lesion was located in a coronary artery.A 182cm mailman guidewire was selected for use.The selected balloon was difficult to advance over the guidewire, and a foreign object was noticed on the guidewire.The guidewire was removed, and the procedure was completed with a different device.There were no patient complications reported.

• Brand Name: MAILMAN
• Common Device Name: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 302 parkway, global park; la aurora - heredia ; CS
• Manufacturer Contact: mark mischke ; 4100 hamline ave n; arden hills, MN 55112 ; 7634941632
• MDR Report Key: 23089477
• Report Number: 2124215-2025-63439
• Device Sequence Number: 10559270
• Product Code: DQX
• UDI-Device Identifier: 08714729165729
• UDI-Public: (01)08714729165729(17)260809(10)34610503
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• PMA/510(K) Number: K143587
• 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): 09/18/2025

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 Expiration Date: 08/09/2026
• Device Model Number: 2735
• Device Catalogue Number: 2735
• Device Lot Number: 0034610503
• 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: 08/25/2025
• Initial Report FDA Received Date: 09/18/2025
• Date Device Manufactured: 08/09/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown