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

Model Number	H7493960815300
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/01/2025
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.Good faith effort attempts were made to try and retrieve the device status, but it was unable to be obtained.
Event or Problem Description
It was reported that balloon burst.A 3.00 x 15mm agent drug-coated balloon (dcb) was selected for percutaneous coronary intervention (pci).During procedure, it was noted that the balloon burst.Procedure was completed using alternate 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): HEMOTEQ AG; adenauerstrasse 15; wuerselen 52146 ; GM 52146
• Manufacturer Contact: mark mischke ; 4100 hamline ave n; arden hills, MN 55112 ; 7634941632
• MDR Report Key: 22297590
• Report Number: 2124215-2025-40613
• Device Sequence Number: 8629015
• Product Code: OOB
• UDI-Device Identifier: 00191506014759
• UDI-Public: (01)00191506014759(17)260513(10)4529H24
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/20/2025

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: H7493960815300
• Device Catalogue Number: H7493960815300
• Device Lot Number: 04529H24
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/28/2025
• Initial Report FDA Received Date: 06/20/2025
• 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