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

Model Number	H7493960820350
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/23/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a balloon rupture occurred.An agent us mr 3.50 x 20mm was selected for treatment of the target lesion.During the procedure, as the balloon was initially inflated it burst.Another of the same device was used to successfully complete the procedure, and there were no patient complications.
Additional Manufacturer Narrative
The returned product consisted of the agent balloon.A visual inspection showed no issues.A microscopic inspection showed a pinhole at 4mm distal to the distal markerband.The device was attached to an encore inflation device.An attempt was made to inflate the balloon, however the balloon could not inflate.It is possible that interactions of the balloon with the lesions anatomical features, as well as interactions with other ancillary devices used during the procedure contributed to the pinhole noted in the balloon at 4mm distal to the distal markerband.This investigation is assigned a most probable conclusion code of cause not established.
Event or Problem Description
It was reported that a balloon rupture occurred.An agent us mr 3.50 x 20mm was selected for treatment of the target lesion.During the procedure, as the balloon was initially inflated it burst.Another of the same device was used to successfully complete the procedure, 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: 24381414
• Report Number: 2124215-2026-09177
• Device Sequence Number: 21378798
• Product Code: OOB
• UDI-Device Identifier: 00191506014834
• UDI-Public: (01)00191506014834(17)261107(10)11621H24
• Combination Product (Y/N): Y
• Initial Reporter State: TN
• 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: Other,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/27/2026

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: H7493960820350
• Device Catalogue Number: H7493960820350
• Device Lot Number: 11621H24
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/23/2026
• Supplement Date Received by Manufacturer: 03/31/2026
• Initial Report FDA Received Date: 02/18/2026
• Supplement Report FDA Received Date: 04/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/07/2024
• 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