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

Model Number	H7493960820400
Medical Device Problem Codes	Break (1069); Fluid/Blood Leak (1250); Inflation Problem (1310); Nonstandard Device (1420)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/04/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that shaft break occurred.The 90% stenosed target lesion was located in moderately calcified and tortuous left main and circumflex bifurcation.The lesion was prepared with an nc emerge balloon.A 4.00 x 20mm agent drug-coated balloon (dcb) was selected for percutaneous coronary intervention (pci) and was delivered to lesion easily.As the physician started to inflate the balloon, it would not come to pressure and there was leak.Physician applied a negative pressure and started to remove balloon, on withdrawing the balloon shaft fully broke.The balloon catheter was removed successfully.The procedure was completed with another same device and there were no patient complications.

• 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: 25318073
• Report Number: 2124215-2026-28624
• Device Sequence Number: 10002664
• Product Code: OOB
• UDI-Device Identifier: 00191506014841
• Combination Product (Y/N): Y
• Initial Reporter State: OK
• 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: 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?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: H7493960820400
• Device Catalogue Number: H7493960820400
• Device Lot Number: 11080H24
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 06/30/2026
• 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: 05/07/2026
• Supplement Date Received by Manufacturer: 08/04/2026
• Initial Report FDA Received Date: 05/28/2026
• Supplement Report FDA Received Date: 09/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/24/2024
• 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
• Patient Sex: Unknown