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

Model Number	H7493960820300
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/25/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the shaft broke.An agent us mr 3.00 x 20mm was selected for treatment of the target lesion.During the procedure while inside the guide catheter, the agent balloon shaft broke.There were no patient complications.
Additional Manufacturer Narrative
With all the available information, boston scientific concludes: device history record review: a review of the device history record (dhr) was performed.The review of the dhr identified that there were no process related non-conformances, scrap, or rework performed during the production that could explain the event.The reviews ensure each device meets specification prior to release for use.There is no indication the device manufacturing process contributed to the event.Device technical analysis: the device was not analyzed as it was not returned to the complaint investigation site for analysis.Labeling review: based on the information provided, there is no evidence that the device was used in a manner inconsistent with the labelled indications.Risk review: a risk review was performed, and it confirmed that the event was defined in the risk documentation and is recorded accordingly in the product record review (prr) table.This event type has been accounted for during product risk analysis to support acceptable risk benefit for the product.Investigation conclusion: without a returned device it is not possible to confirm the complaint allegation, and it is not possible to determine if there is any damage present along the device which could have contributed to the complaint event.This investigation is assigned a most probable investigation conclusion code of cause not established.
Event or Problem Description
It was reported that the shaft broke.An agent us mr 3.00 x 20mm was selected for treatment of the target lesion.During the procedure while inside the guide catheter, the agent balloon shaft broke.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): FREUDENBERG MEDICAL; adenauerstrasse 15; wuerselen 52146 ; GM 52146
• Manufacturer Contact: mark mischke ; 4100 hamline ave n; arden hills, MN 55112 ; 7634941632
• MDR Report Key: 24650604
• Report Number: 2124215-2026-15536
• Device Sequence Number: 9786919
• Product Code: OOB
• UDI-Device Identifier: 00191506014827
• UDI-Public: (01)00191506014827(17)260201(10)1058H24
• Combination Product (Y/N): Y
• Initial Reporter State: TX
• 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): 05/07/2026

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 Expiration Date: 02/01/2026
• Device Model Number: H7493960820300
• Device Catalogue Number: H7493960820300
• Device Lot Number: 01058H24
• 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: 02/23/2026
• Supplement Date Received by Manufacturer: 04/09/2026
• Initial Report FDA Received Date: 03/20/2026
• Supplement Report FDA Received Date: 05/07/2026
• Date Device Manufactured: 02/02/2024
• 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: 89 YR
• Patient Sex: Male
• Patient Weight: 69 KG