MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION AGENT?; Drug-eluting percutaneous transluminal coronary angioplasty catheter

Model Number	H7493960830400
Medical Device Problem Codes	Nonstandard Device (1420); Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/12/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a balloon rupture occurred.A 4.00 mm x 30.00 mm agent drug-coated balloon (dcb) was selected for an in-stent restenosis (isr) treatment.The balloon ruptured immediately during the initial inflation attempt.The device was removed from patient; the procedure was successfully completed with an alternative device.There was no patient complication reported.
Event or Problem Description
It was reported that a balloon rupture occurred.A 4.00 mm x 30.00 mm agent drug-coated balloon (dcb) was selected for an in-stent restenosis (isr) treatment.The balloon ruptured immediately upon launch without inflation.The guide catheter was also positioned within the vessel at the time of the event.The device was removed from patient; the procedure was successfully completed with an alternative device.There was no patient complication reported.
Additional Manufacturer Narrative
Investigation results: device analysis findings: the device was returned for analysis.Visual, tactile, and microscopic analysis were performed on the device.A detailed microscopic examination of the balloon material identified a pinhole, located approximately 10 mm proximal to distal markerband.A detailed microscopic examination identified slightly stretching of the inner lumen.No other device issues were identified during returned product analysis.Device history record (dhr) review: review confirmed that the device met all material, assembly, and performance specifications prior to distribution.Labeling review: review of the instructions for use (ifu) confirmed there was relevant content and sufficient guidance with respect to the circumstances described within this complaint.No updates are required to the ifu as a result of this event.Risk review: a risk review was performed and confirmed that the event was defined in the risk documentation.This event type has been accounted for during product risk analysis to support acceptable risk benefit for the product.Investigation conclusion: this investigation is assigned a most probable investigation conclusion code of cause not established.The information available is insufficient to establish the cause of the reported event.While procedural and anatomical factors cannot be evaluated due to the limited information provided, no definitive cause could be identified.Returned product analysis also identified stretching of the inner lumen, most likely resulting from contact with the guide catheter and guidewire.The most probable cause of this damage is the application of unintended excessive force to the delivery system during device withdrawal.

• 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 ; +1(763)494-1632
• MDR Report Key: 25774276
• Report Number: 2124215-2026-37034
• Device Sequence Number: 13147857
• Product Code: OOB
• UDI-Device Identifier: 00191506014919
• 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
• 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): 09/09/2026

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: H7493960830400
• Device Catalogue Number: H7493960830400
• Device Lot Number: 08611H25
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/08/2026
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/15/2026
• Supplement Date Received by Manufacturer: 08/21/2026
• Initial Report FDA Received Date: 07/09/2026
• Supplement Report FDA Received Date: 09/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/13/2025
• 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