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

Model Number	H7493960820300
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/07/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the balloon ruptured.The patient presented with in-stent restenosis (isr) for a percutaneous coronary intervention (pci).A 3.00 mm x 20.00 mm agent drug-coated balloon (dcb) was used at the right coronary artery (rca).Vessel preparation was initiated with plain old balloon angioplasty (poba) using an emerge balloon, followed by intravascular lithotripsy (ivl).The agent device was found to be undamaged during unpacking and preparation for use, and it advanced smoothly over the wire and through the guidewire without any difficulty.The agent dcb was advanced; however, the balloon ruptured at 6 atm.The procedure was successfully completed with another agent device.There was no patient complication reported, and the patient was doing well post procedure.

• 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: 22701416
• Report Number: 2124215-2025-53937
• Device Sequence Number: 9150392
• Product Code: OOB
• UDI-Device Identifier: 00191506014827
• UDI-Public: (01)00191506014827(17)260425(10)3455H24
• Combination Product (Y/N): Y
• Initial Reporter State: NJ
• 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): 08/04/2025

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: 04/25/2026
• Device Model Number: H7493960820300
• Device Catalogue Number: H7493960820300
• Device Lot Number: 03455H24
• 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: 07/10/2025
• Initial Report FDA Received Date: 08/04/2025
• Date Device Manufactured: 04/25/2024
• 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