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

Model Number	2777
Medical Device Problem Codes	Nonstandard Device (1420); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	08/01/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
B3: date of event: used the first day of the aware date month as the event date as it was not provided.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 distal tip detachment occurred.A 185cm pt2 guidewire was selected for used; however, during the procedure, the tip of the wire broke off into a small branch of a distal coronary artery.The wire fragment was not able to be retrieved.No further information provided.
Additional Manufacturer Narrative
B3: date of event: used the first day of the aware date month as the event date as it was not provided.Good faith effort attempts were made to try and retrieve additional details regarding the reported event, but further information was unable to be obtained.Device evaluated by mfr.: the 185cm pt2 guidewire was returned for analysis.Visual, microscopic, and dimensional inspection was performed on the device.Visual and microscopic inspection revealed the distal tip was bent, and a portion of it was detached and was not returned for analysis.The total length of the guidewire was measured from proximal to distal and it was noted that 1.5 inches of the distal tip was missing.
Event or Problem Description
It was reported that distal tip detachment occurred.A 185cm pt2 guidewire was selected for used; however, during the procedure, the tip of the wire broke off into a small branch of a distal coronary artery.The wire fragment was not able to be retrieved.No further information provided.

• Brand Name: PT
• 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: 22901455
• Report Number: 2124215-2025-57729
• Device Sequence Number: 13033836
• Product Code: DQX
• UDI-Device Identifier: 08714729471196
• UDI-Public: (01)08714729471196(17)260619(10)34275978
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K030617
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/10/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/19/2026
• Device Model Number: 2777
• Device Catalogue Number: 2777
• Device Lot Number: 0034275978
• 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: 08/01/2025
• Supplement Date Received by Manufacturer: 11/19/2025
• Initial Report FDA Received Date: 08/27/2025
• Supplement Report FDA Received Date: 12/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/19/2024
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown