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

Model Number	81715
Medical Device Problem Codes	Nonstandard Device (1420); Failure to Advance (2524); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/16/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A2: age at time of event: 18 years or older.
Event or Problem Description
It was reported that tip damage occurred.The 100% stenosed target lesion was located in the moderately tortuous and moderately calcified left hand shunt vessels.A 165 cm transend guidewire was selected for use in a shunt percutaneous transluminal angioplasty.During the procedure, the device was advanced into an occluded lesion, but it could not cross through the lesion.The device was removed and upon visual inspection, the tip appeared worn.The procedure was completed with another of the same device.There were no patient complications as a result of this event.
Additional Manufacturer Narrative
A2 - age at time of event: 18 years or older.Updated e1: initial reporter email.Device evaluated by mfr: the guidewire was returned to our post market quality assurance laboratory.Visual inspection of the device revealed that the guidewire was bent at the distal tip.
Event or Problem Description
It was reported that tip damage occurred.The 100% stenosed target lesion was located in the moderately tortuous and moderately calcified left hand shunt vessels.A 165cm transend guidewire was selected for use in a shunt percutaneous transluminal angioplasty.During the procedure, the device was advanced into an occluded lesion, but it could not cross through the lesion.The device was removed and upon visual inspection, the tip appeared worn.The procedure was completed with another of the same device.There were no patient complications as a result of this event.

• 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: 23535052
• Report Number: 2124215-2025-80739
• Device Sequence Number: 21374193
• Product Code: DQX
• UDI-Device Identifier: 08714729326304
• UDI-Public: (01)08714729326304(17)270512(10)36498387
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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,Followup
• 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: 81715
• Device Catalogue Number: 81715
• Device Lot Number: 0036498387
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/16/2025
• Supplement Date Received by Manufacturer: 11/26/2025
• Initial Report FDA Received Date: 11/12/2025
• Supplement Report FDA Received Date: 12/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/12/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: GUIDEWIRE-TRANSCEND18; GUIDEWIRE-TRANSCEND18
• Patient Sex: Female