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

Model Number	H7493960815400
Medical Device Problem Codes	Break (1069); Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/28/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a shaft break occurred.The 90% stenosed target lesion was located in a moderately tortuous and severely calcified distal right coronary artery (rca).A 4.00 mm x 15.00 mm agent drug coated balloon (dcb) was selected for treatment.During the procedure, while the physician was advancing the balloon, it snapped at the mid shaft.The device was removed as a single unit, and the procedure was completed using a different device.
Event or Problem Description
It was reported that a shaft break occurred.The 90% stenosed target lesion was located in a moderately tortuous and severely calcified distal right coronary artery (rca).A 4.00 mm x 15.00 mm agent drug coated balloon (dcb) was selected for treatment.During the procedure, while the physician was advancing the balloon, it snapped at the mid shaft.The device was removed as a single unit, and the procedure was completed using a different device.It was further reported that the user encounter resistance while advancing the device.It was fractured on the balloon shaft.And there was no patient complications.
Additional Manufacturer Narrative
B5, describe event or problem, updated with additional information.

• 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: 50334625
• Report Number: 2124215-2026-44773
• Device Sequence Number: 17510108
• Product Code: OOB
• UDI-Device Identifier: 00191506014773
• Combination Product (Y/N): Y
• Initial Reporter State: PA
• 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): 09/10/2026

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 Expiration Date: 09/11/2026
• Device Model Number: H7493960815400
• Device Catalogue Number: H7493960815400
• Device Lot Number: 09315H24
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/24/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 08/19/2026
• Initial Report FDA Received Date: 08/19/2026
• Supplement Report FDA Received Date: 09/10/2026
• Date Device Manufactured: 09/11/2024
• 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