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

Model Number	H7493960830300
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/09/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the balloon failed to exit the guide catheter requiring additional intervention.An agent (dcb) was selected for a percutaneous coronary intervention in the examination of the right coronary artery.During the procedure the lesion was pretreated with balloons and then a synergy xd stent was implanted.The agent dcb was attempted but would barley come out of the guide catheter and a guidezilla was needed to remove it.No patient complications reported.
Event or Problem Description
It was reported that the agent balloon failed to exit the guide catheter and required another device for complete removal.An agent (dcb) was selected for a percutaneous coronary intervention in the examination of the right coronary artery.During the procedure the lesion was pretreated with balloons and then a synergy xd stent was implanted.The agent dcb was attempted but would barley come out of the guide catheter and a guidezilla was needed to remove it.No patient complications reported.
Additional Manufacturer Narrative
Investigation results device analysis findings: the device was not returned for analysis; therefore, a technical analysis could not be performed.Device history record (dhr) review: it was confirmed that this device met manufacturing specification prior to distribution and there no manufacturing deviations which could have contributed to the reported event.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: boston scientific has assigned an investigation conclusion code of cause not established based upon the information available.It was reported that the device experienced difficulty to advance through the guide catheter.Due to limited information received, it was difficult to confirm the reported complaint allegation, what caused the failure and if any visual damage contributed to the allegation.However, it was determined that the device met manufacturing specification prior to distribution and there were no manufacturing deviations that contributed to the reported event.

• 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: 25749333
• Report Number: 2124215-2026-36550
• Device Sequence Number: 16055648
• Product Code: OOB
• UDI-Device Identifier: 00191506014896
• UDI-Public: (01)00191506014896(17)270206(10)1371H25
• 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
• 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): 08/17/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: H7493960830300
• Device Catalogue Number: H7493960830300
• Device Lot Number: 01371H25
• Was Device Available for Evaluation?: No
• 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: 06/09/2026
• Supplement Date Received by Manufacturer: 07/23/2026
• Initial Report FDA Received Date: 07/08/2026
• Supplement Report FDA Received Date: 08/18/2026
• Date Device Manufactured: 02/06/2025
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown