MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION AGENT?; Drug-eluting percutaneous transluminal coronary angioplasty catheter

Model Number	H7493960815250
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Cardiac Enzyme Elevation (1838); Myocardial Infarction (1969)
Date of Event	05/07/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that patient complications occurred.A loading dose of 324 mg of aspirin and 600 mg of clopidogrel were given prior to the procedure.The 8.00 mm x 2.50 mm target lesion was located in the first diagonal branch of the left anterior descending artery (lad).The target lesion was pre-treated with a 2.50 mm x 15 mm non-compliant balloon angioplasty catheter resulting in 10% residual stenosis and timi flow 3.The target lesion was then successfully treated with a 2.50 mm x 15 mm agent dcb resulting in 0% residual stenosis and timi flow of 3.An additional 28 mm x 3.00 mm target lesion located from the proximal to mid lad was pre-treated with a 2.50 x 15 mm semi-compliant balloon angioplasty catheter resulting in 30% residual stenosis and timi flow of 3.The lesion was further treated with a 3.00 mm x 33 mm non-boston scientific drug eluting stent resulting in 0% residual stenosis and timi flow of 3.A non-target lesion located in the mid right coronary artery (rca) was successfully treated prior to the treatment of target lesion using a 4.00 mm x 28 mm drug eluting stent and a 4.00 mm x 15 mm balloon angioplasty catheter.Post-procedure, elevated cardiac enzymes were detected, and the patient was diagnosed with myocardial infarction.The patient was discharged from the hospital with the continuation of aspirin and clopidogrel medications.

• Brand Name: AGENT?
• Common Device Name: Drug-eluting percutaneous transluminal coronary angioplasty catheter
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): FREUDENBERG MEDICAL; adenauerstrasse 15; wuerselen 52146 ; GM 52146
• Manufacturer Contact: mark mischke ; 4100 hamline ave n; arden hills, MN 55112 ; +1(763)494-1632
• MDR Report Key: 50073432
• Report Number: 2124215-2026-40663
• Device Sequence Number: 21386519
• Product Code: OOB
• UDI-Device Identifier: 00191506014735
• UDI-Public: (01)00191506014735(17)261002(10)10159H24
• Combination Product (Y/N): Y
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: P230035
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/10/2026

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 10/02/2026
• Device Model Number: H7493960815250
• Device Catalogue Number: H7493960815250
• Device Lot Number: 10159H24
• 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: 07/07/2026
• Supplement Date Received by Manufacturer: 08/17/2026
• Initial Report FDA Received Date: 07/29/2026
• Supplement Report FDA Received Date: 09/10/2026
• Date Device Manufactured: 10/02/2024
• 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 Age: 81 YR
• Patient Sex: Female