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

Model Number	H74938931010
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	Chest Pain (1776); Foreign Body In Patient (2687); Foreign Body Embolism (4439); Back pain (4895)
Date of Event	11/01/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a device issue occurred resulting in patient complications.On an unknown date in 2021, the patient underwent a percutaneous coronary intervention (pci) at an unknown facility.During the procedure, a185cm straight pt2 guidewire was cut in the left circumflex artery (lcx).Retrieval was unsuccessful, and the fragment remained inside the body.In (b)(6) 2026, the patient presented with chest pain and was hospitalized.Coronary angiogram (cag) was performed to investigate the chest pain.A 75% stenosed lesion was located in the non-tortuous lcx.During the cag, the previously retained guidewire fragment was no longer visible on fluoroscopy.A non-contrast ct scan was also performed and demonstrated that the high-attenuation structure previously observed in that same area had disappeared.As per radiologist interpretation, a high-attenuation structure of similar size was identified within the splenic artery.No additional details were provided.
Additional Manufacturer Narrative
B3 date of event was estimated based on device detachment occurring in 2021.E1.Initial reporter facility name: (b)(6) l medical center.Detailed product information was not provided to bsc.We completed a good faith effort to obtain the information, but it was unable to be obtained.Because the product is unknown, we are unable to provide the unique identifier (udi) # and other specific product information.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(763)494-1632
• MDR Report Key: 50074274
• Report Number: 2124215-2026-40690
• Device Sequence Number: 10250586
• Product Code: DQX
• UDI-Device Identifier: 08714729471103
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/02/2026

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: H74938931010
• Device Catalogue Number: H74938931010
• 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: 07/08/2026
• Supplement Date Received by Manufacturer: 08/03/2026
• Initial Report FDA Received Date: 07/29/2026
• Supplement Report FDA Received Date: 09/02/2026
• 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; Hospitalization
• Patient Sex: Unknown