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

Model Number	H7493960815300
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/26/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Good faith effort attempts were made to try and retrieve additional details regarding the reported event, but further information was unable to be obtained.
Event or Problem Description
It was reported that the balloon came off the shaft.A 3.00 mm x 15.00 mm agent drug-coated balloon (dcb) was selected for a coronary artery disease (cad) treatment.During the procedure, the balloon came off the shaft.The device was removed.There were no patient complications, and the patient was fully recovered after the 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): FREUDENBERG MEDICAL; adenauerstrasse 15; wuerselen 52146 ; GM 52146
• Manufacturer Contact: mark mischke ; 4100 hamline ave n; arden hills, MN 55112 ; 7634941632
• MDR Report Key: 24981825
• Report Number: 2124215-2026-22294
• Device Sequence Number: 10468365
• Product Code: OOB
• UDI-Device Identifier: 00191506014759
• UDI-Public: (01)00191506014759(17)270220(10)1793H25
• Combination Product (Y/N): Y
• Initial Reporter State: AZ
• 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,Followup
• Report Date (Section B): 06/10/2026

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: H7493960815300
• Device Catalogue Number: H7493960815300
• Device Lot Number: 01793H25
• 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: 04/02/2026
• Supplement Date Received by Manufacturer: 05/29/2026
• Initial Report FDA Received Date: 04/24/2026
• Supplement Report FDA Received Date: 06/10/2026
• Date Device Manufactured: 02/20/2025
• 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