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

Model Number	H7493960830400
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/11/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a balloon rupture occurred.The target lesion was located in the proximal right coronary artery.The 4.00 x 30mm agent dcb was introduced to treat the target lesion but the balloon material ruptured.The procedure was completed with a balloon angioplasty catheter resulting in 25% residual stenosis and timi 3 flow.
Event or Problem Description
It was reported that a balloon rupture occurred.The target lesion was located in the proximal right coronary artery.The 4.00 x 30mm agent dcb was introduced to treat the target lesion but the balloon material ruptured.The procedure was completed with a balloon angioplasty catheter resulting in 25% residual stenosis and timi 3 flow.It was additionally reported that the target lesion was 50% stenosed, and the agent dcb was inflated to 14 atm for 25 to 30 seconds when it ruptured.

• 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: 21700336
• Report Number: 2124215-2025-18785
• Device Sequence Number: 20800406
• Product Code: OOB
• UDI-Device Identifier: 00191506014919
• UDI-Public: 00191506014919
• Combination Product (Y/N): Y
• 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: Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/22/2025

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: 02/26/2026
• Device Model Number: H7493960830400
• Device Catalogue Number: H7493960830400
• Device Lot Number: 01968H24
• 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: 03/21/2025
• Supplement Date Received by Manufacturer: 03/28/2025
• Initial Report FDA Received Date: 03/26/2025
• Supplement Report FDA Received Date: 04/22/2025
• Date Device Manufactured: 02/27/2024
• 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 Age: 75 YR
• Patient Sex: Male
• Patient Race: White