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

Model Number	H7493893103J0
Medical Device Problem Codes	Fracture (1260); Nonstandard Device (1420)
Health Effect - Clinical Code	Embolism/Embolus (4438)
Date of Event	08/05/2025
Type of Reportable Event	Serious Injury
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 guidewire fracture and embolism occurred.The severely occluded target lesion was located in the posterior descending branch.A 185cm j-tip, pt2 guidewire was selected for use.However, the wire broke and embolized into the vessel.The device was removed with no patient complications reported.
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.The device was returned for analysis split in two pieces.Visual and microscopic inspection also revealed the distal tip was kinked.Dimensional inspection showed the detachment was found at a distance of 14.13 inches.The overall length of the returned device was within specification.
Event or Problem Description
It was reported that guidewire fracture and embolism occurred.The severely occluded target lesion was located in the posterior descending branch.A 185cm j-tip, pt2 guidewire was selected for use.However, the wire broke and embolized into the vessel.The device was removed with no patient complications reported.

• 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: 22834525
• Report Number: 2124215-2025-57227
• Device Sequence Number: 9430986
• Product Code: DQX
• UDI-Device Identifier: 08714729471202
• UDI-Public: (01)08714729471202(17)260107(10)33164542
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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: Other,Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/04/2025

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: 01/07/2026
• Device Model Number: H7493893103J0
• Device Catalogue Number: H7493893103J0
• Device Lot Number: 0033164542
• 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: 08/14/2025
• Supplement Date Received by Manufacturer: 11/21/2025
• Initial Report FDA Received Date: 08/18/2025
• Supplement Report FDA Received Date: 12/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/08/2024
• 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