MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION PT?; wire, guide, catheter

Model Number	H7493893103J0
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	05/26/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that guidewire fracture occurred resulting in additional intervention.The target lesion was located in the left main coronary artery (lmca).A 185cm pt2 guidewire was selected for use.However, during the procedure, it was observed that the guidewire fractured within the lmca.An attempt was made to retrieve the fractured guidewire using a small-balloon capture technique; however, the retrieval attempt was unsuccessful.The physician decided to move the device fragment to a marginal branch.The procedure was completed without any patient complications.The patient was stable post-procedure.
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.

• 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 ; +1(612)875-7234
• MDR Report Key: 50613298
• Report Number: 2124215-2026-47313
• Device Sequence Number: 10711491
• Product Code: DQX
• UDI-Device Identifier: 08714729471202
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K030617
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 09/30/2026

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 Model Number: H7493893103J0
• Device Catalogue Number: H7493893103J0
• Device Lot Number: 0037921864
• 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: Not provided
• Supplement Date Received by Manufacturer: 09/08/2026
• Initial Report FDA Received Date: 09/04/2026
• Supplement Report FDA Received Date: 09/30/2026
• Date Device Manufactured: 11/10/2025
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown