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

Model Number	H7493960830250
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/14/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluated by manufacturer: a 2.50 x 30 mm agent device was returned for analysis.Visual, tactile, microscopic analysis and functional testing was performed on the device.A visual inspection of the outer and inner lumen and tactile examination of the entire extrusion found no issues.A detailed microscopic examination of the balloon material identified no tears or pinholes in the balloon.Bumper tip showed no signs of distal tip damage.The device was attached to an encore inflation device.An attempt was then made to inflate the balloon; however, it was observed that a leak was occurring.A shaft tear was identified during microscopic examination in the polymer extrusions outer lumen just distal to the port exchange.Inspection of the remainder of the device presented no other damage or irregularities.
Event or Problem Description
It was reported that failure to inflate.The patient presented with coronary artery disease (cad).A 2.50 x 30 mm agent drug-coated balloon (dcb) was selected for percutaneous coronary intervention (pci).During the procedure, the balloon was delivered but failed to inflate; even after removing it from the body, it remained non-inflated.The procedure was successfully completed using another device, with no patient complications and the patient full recovered.However, the return device analysis revealed a shaft tear in the polymer extrusion and leak occurred.

• 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: 24474923
• Report Number: 2124215-2026-11175
• Device Sequence Number: 16017956
• Product Code: OOB
• UDI-Device Identifier: 00191506014872
• UDI-Public: (01)00191506014872(17)260827(10)8754H24
• Combination Product (Y/N): Y
• Initial Reporter State: WA
• 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
• Report Date (Section B): 02/27/2026

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: 08/27/2026
• Device Model Number: H7493960830250
• Device Catalogue Number: H7493960830250
• Device Lot Number: 08754H24
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/06/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/04/2026
• Initial Report FDA Received Date: 02/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/27/2024
• 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