MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION AGENT?; DRUG-ELUTING PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY CATHETER

Model Number	H7493960820400
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Itching Sensation (1943); Rash (2033); Discomfort (2330)
Date of Event	11/20/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that upper chest discomfort, pruritus and rash occurred.A 4.00 x 20 mm agent drug-coated balloon (dcb) was used in the patient's saphenous vein graft.Following the procedure, the patient developed an upper chest rash with associated pruritus.The physician prescribed antihistamines (zyrtec) and a beta blocker to manage the symptoms; however, the patient has continued to experience discomfort since (b)(6) 2025.
Event or Problem Description
It was reported that upper chest discomfort, pruritus and rash occurred.A 4.00 x 20 mm agent drug-coated balloon (dcb) was used in the patient's saphenous vein graft.Following the procedure, the patient developed an upper chest rash with associated pruritus.The physician prescribed antihistamines (zyrtec) and a beta blocker to manage the symptoms; however, the patient has continued to experience discomfort since (b)(6) 2025.
Additional Manufacturer Narrative
G1: added mfr site facility name, address 1, city, code and country.

• 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): HEMOTEQ AG; adenauerstrasse 15; wuerselen 52146 ; GM 52146
• Manufacturer Contact: mark mischke ; 4100 hamline ave n; arden hills, MN 55112 ; 7634941632
• MDR Report Key: 23805223
• Report Number: 2124215-2025-90889
• Device Sequence Number: 7622326
• Product Code: OOB
• UDI-Device Identifier: 00191506014841
• UDI-Public: (01)00191506014841
• Combination Product (Y/N): Y
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: P230035
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/15/2025

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: H7493960820400
• Device Catalogue Number: H7493960820400
• 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: 11/20/2025
• Supplement Date Received by Manufacturer: 11/20/2025
• Initial Report FDA Received Date: 12/15/2025
• Supplement Report FDA Received Date: 12/15/2025
• 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