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

Model Number	H7493960820300
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Vascular Dissection (3160)
Date of Event	07/06/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a grade b dissection followed by bailout stenting occurred.The patient was on a prior regimen of aspirin (>= 72 hours) and antiplatelet other than aspirin (>= 72 hours).At the time of the procedure, the patient received heparin or other antithrombotic medication and a loading dose of 325 mg of aspirin and 300 mg of clopidogrel.The 2.75 mm x 18 mm target lesion located at the proximal right coronary vessel was pretreated with three devices using the largest balloon diameter of 2.5 mm x 15 mm wolverine cutting balloon and non-compliant balloon angioplasty catheter resulting in 30% residual stenosis and timi flow of 3.The target lesion was then successfully treated with a 3.0 mm x 20 mm agent dcb device achieving 0% stenosis and timi flow of 3.Post treatment with the agent dcb device, a grade b dissection was discovered that required the use of a 3.0 mm x 32 mm synergy xd stent for a successful bailout stenting procedure.The patient was discharged with the continuation of aspirin and clopidogrel.

• 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(612)875-7234
• MDR Report Key: 50229874
• Report Number: 2124215-2026-43365
• Device Sequence Number: 10273681
• Product Code: OOB
• UDI-Device Identifier: 00191506014827
• UDI-Public: (01)00191506014827(17)270703(10)7060H25
• Combination Product (Y/N): Y
• Initial Reporter State: CA
• 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): 09/14/2026

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 Model Number: H7493960820300
• Device Catalogue Number: H7493960820300
• Device Lot Number: 07060H25
• 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: 07/21/2026
• Supplement Date Received by Manufacturer: 08/21/2026
• Initial Report FDA Received Date: 08/12/2026
• Supplement Report FDA Received Date: 09/14/2026
• Date Device Manufactured: 07/03/2025
• 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 Age: 60 YR
• Patient Sex: Male
• Patient Weight: 204 LB