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

Model Number	H7493960815350
Medical Device Problem Codes	Break (1069); Difficult to Advance (2920); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/02/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a shaft break occurred.An agent us mr 3.50 x 15mm was selected for treatment of the target lesion, which was located in the proximal circumflex.Following ivus, the physician began attempting to advance the agent balloon.It was noted that there was difficulty advancing the balloon.When attempting to properly position the balloon, the proximal end of the device broke, just before the balloon.The physician was able to completely remove the agent from the patient, and another similar device was used to successfully complete the procedure.There were no patient complications.
Event or Problem Description
It was reported that a shaft break occurred.An agent us mr 3.50 x 15mm was selected for treatment of the target lesion, which was located in the proximal circumflex.Following ivus, the physician began attempting to advance the agent balloon.It was noted that there was difficulty advancing the balloon.When attempting to properly position the balloon, the proximal end of the device broke, just before the balloon.The physician was able to completely remove the agent from the patient, and another similar device was used to successfully complete the procedure.There were no patient complications.
Additional Manufacturer Narrative
The returned product consisted of the agent balloon and catheter.A visual examination of the device revealed a break 18cm distal to the end of the strain relief with multiple kinks along the hypotube shaft.There were no other damages or defects discovered.

• 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: 22395731
• Report Number: 2124215-2025-43191
• Device Sequence Number: 14677786
• Product Code: OOB
• UDI-Device Identifier: 00191506014766
• UDI-Public: (01)00191506014766(17)260411(10)3465H24
• Combination Product (Y/N): Y
• Initial Reporter State: MN
• 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): 08/25/2025

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: 04/11/2026
• Device Model Number: H7493960815350
• Device Catalogue Number: H7493960815350
• Device Lot Number: 03465H24
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/17/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/02/2025
• Supplement Date Received by Manufacturer: 07/29/2025
• Initial Report FDA Received Date: 07/03/2025
• Supplement Report FDA Received Date: 08/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/11/2024
• 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