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

Model Number	M001468100
Medical Device Problem Codes	Failure to Advance (2524); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/21/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluated by mfr: the complaint device was returned to our post market quality assurance laboratory.Visual and microscopic inspections were performed, it was possible to see that the distal tip was bent, and the proximal section of the guidewire was bent as well.Additionally, the ptfe coating was peeled at the proximal section.No other issues were identified during the product analysis.
Event or Problem Description
Reportable based on device analysis completed on 18nov2025.It was reported that the device was difficult to cross the lesion.The 100% stenosed target lesion was located in the liver.A 135cm transend guidewire was selected for transarterial chemoembolization (tace).During the procedure, it was noted that device could not cross the lesion.The procedure was completed with another of the same device.There were no patient complications as a result of this event.However, device analysis revealed the ptfe coating was peeled at the proximal section.

• Brand Name: TRANSEND?
• 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: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 23802269
• Report Number: 2124215-2025-90761
• Device Sequence Number: 9360467
• Product Code: DQX
• UDI-Device Identifier: 08714729326274
• UDI-Public: (01)08714729326274(17)270307(10)36018032
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K941710
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/15/2025

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: M001468100
• Device Catalogue Number: M001468100
• Device Lot Number: 0036018032
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/13/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/18/2025
• Initial Report FDA Received Date: 12/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/07/2025
• 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 Age: 68 YR
• Patient Sex: Male