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

Model Number	H7493960815350
Medical Device Problem Codes	Break (1069); Entrapment of Device (1212); Deformation Due to Compressive Stress (2889); Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/11/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that device entrapped and shaft break occurred.The patient presented with coronary artery disease.A 3.50 x 15 mm agent drug-coated balloon (dcb) was selected for percutaneous coronary intervention (pci).During insertion, the balloon became stuck within the guide extension, resulting in shaft bent and brake.The procedure was successfully completed with another device.There was no patient complications reported, and the patient was fully recovered.
Additional Manufacturer Narrative
H6: device codes updated.
Event or Problem Description
It was reported that device entrapped and shaft break occurred.The patient presented with coronary artery disease.A 3.50 x 15 mm agent drug-coated balloon (dcb) was selected for percutaneous coronary intervention (pci).During insertion, the balloon became stuck within the guide extension, resulting in shaft bent and brake.The procedure was successfully completed with another device.There was no patient complications reported, and the patient was fully recovered.

• 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: 23756759
• Report Number: 2124215-2025-89782
• Device Sequence Number: 13118761
• Product Code: OOB
• UDI-Device Identifier: 00191506014766
• UDI-Public: (01)00191506014766(17)270312(10)2557H25
• Combination Product (Y/N): Y
• Initial Reporter State: IL
• 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): 01/02/2026

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 Model Number: H7493960815350
• Device Catalogue Number: H7493960815350
• Device Lot Number: 02557H25
• 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: 11/12/2025
• Supplement Date Received by Manufacturer: 12/11/2025
• Initial Report FDA Received Date: 12/09/2025
• Supplement Report FDA Received Date: 01/02/2026
• Date Device Manufactured: 03/12/2025
• 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