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

Model Number	H7493893103J0
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	02/23/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that tip detachment occurred.The patient, who had severe coronary artery disease and had already undergone 5 stents implantation, came to the hospital to treat 2 more lesions in the circumflex artery.A 185cm j-tip, 1-pack pt2 guidewire was selected for use.During the procedure, 2 additional stents were successfully implanted without any issues.However, at the end of the procedure, when removing the devices, it was discovered that the tip of the guidewire had broken off and remained in a small branch of the circumflex artery.The procedure was completed without affecting the blood flow.The patient showed no symptoms afterward and remained stable.
Additional Manufacturer Narrative
Device evaluated by mfr: the guidewire was returned for analysis.Visual inspection revealed the body of the guidewire was kinked.Microscope inspection revealed the distal end was detached and was not returned for analysis.Dimensional inspection indicated that 15.1 inches of the distal end were detached and were not returned for analysis.
Event or Problem Description
It was reported that tip detachment occurred.The patient, who had severe coronary artery disease and had already undergone 5 stents implantation, came to the hospital to treat 2 more lesions in the circumflex artery.A 185cm j-tip, 1-pack pt2 guidewire was selected for use.During the procedure, 2 additional stents were successfully implanted without any issues.However, at the end of the procedure, when removing the devices, it was discovered that the tip of the guidewire had broken off and remained in a small branch of the circumflex artery.The procedure was completed without affecting the blood flow.The patient showed no symptoms afterward and remained stable.

• 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: 21597365
• Report Number: 2124215-2025-15685
• Device Sequence Number: 15684693
• Product Code: DQX
• UDI-Device Identifier: 08714729471202
• UDI-Public: 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
• 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): 07/14/2025

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 Expiration Date: 08/27/2026
• Device Model Number: H7493893103J0
• Device Catalogue Number: H7493893103J0
• Device Lot Number: 0034726713
• 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: 02/26/2025
• Supplement Date Received by Manufacturer: 07/09/2025
• Initial Report FDA Received Date: 03/13/2025
• Supplement Report FDA Received Date: 07/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/27/2024
• 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