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

Model Number	H7493960830250
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
B3: as the event date was not reported, the first day in the month of the aware date is provided.
Event or Problem Description
It was reported that balloon detached.A 2.50 mm x 30.00 mm agent (dbc) was selected for percutaneous coronary intervention (pci).During the preparation, the stylet was taken out, the balloon snapped.Procedure was completed with new balloon and no patient complications reported.
Event or Problem Description
It was reported that balloon detached.A 2.50 mm x 30.00 mm agent (dbc) was selected for percutaneous coronary intervention (pci).During the preparation, the stylet was taken out, the balloon snapped.Procedure was completed with new balloon and no patient complications reported.
Additional Manufacturer Narrative
B3: as the event date was not reported, the first day in the month of the aware date is provided.Device evaluated by manufacturer: the returned product consisted of the agent dcb mr 2.50 x 30mm balloon catheter, lot number 04519h24.Visual and tactile inspection found a break 10cm proximal to port exchange.Microscopic analysis noted that a mandrel was returned inserted into the device.A white piece of foreign material (fm) was attached to the mandrel section that was outside of the device.Once the fm was removed the mandrel was removed from the device without any issue.Further examination of the shaft polymer extrusion via microscope noted that there was additional damage present.The outer lumen was kinked and dented.A detailed microscopic examination of the balloon material identified no issues with the balloon.

• 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: 22318805
• Report Number: 2124215-2025-41582
• Device Sequence Number: 8996708
• Product Code: OOB
• UDI-Device Identifier: 00191506014872
• UDI-Public: (01)00191506014872(17)260513(10)4519H24
• Combination Product (Y/N): Y
• Initial Reporter State: MI
• 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): 08/06/2025

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: 05/13/2026
• Device Model Number: H7493960830250
• Device Catalogue Number: H7493960830250
• Device Lot Number: 04519H24
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 07/31/2025
• Initial Report FDA Received Date: 06/24/2025
• Supplement Report FDA Received Date: 08/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/13/2024
• 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