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

Model Number	H7493960820350
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/05/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that shaft broke.A 3.50 x 20mm agent drug-coated balloon (dcb) was selected for percutaneous coronary intervention (pci).During procedure, the shaft broke right proximal to balloon on advancing.The procedure was completed with alternate method.No patient complications were reported.

• 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; GM
• Manufacturer Contact: mark mischke ; 4100 hamline ave n; arden hills, MN 55112 ; +1(763)494-1632
• MDR Report Key: 25654078
• Report Number: 2124215-2026-34530
• Device Sequence Number: 12231708
• Product Code: OOB
• UDI-Device Identifier: 00191506014834
• UDI-Public: (01)00191506014834
• Combination Product (Y/N): Y
• Initial Reporter State: IA
• Initial Reporter Country: US
• PMA/510(K) Number: P230035
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/21/2026

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 Model Number: H7493960820350
• Device Catalogue Number: H7493960820350
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/05/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/29/2026
• Supplement Report FDA Received Date: 08/21/2026
• 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
• Patient Sex: Unknown