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

Model Number	H7493960820400
Medical Device Problem Codes	Break (1069); Failure to Advance (2524); Deformation Due to Compressive Stress (2889); Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/03/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a shaft break occurred.The patient presented with coronary artery disease (cad).A 4.00 x 20 mm agent drug-coated balloon (dcb) was selected for percutaneous coronary intervention (pci).During treatment of the proximal circumflex, other devices such as the ivus catheter and pre-dilation balloons were able to cross the lesion without issue.After lesion preparation, the agent balloon could not be cross lesion and repeated attempts to deliver it caused the guide catheter to back out of the coronary artery multiple times.The hypotube became bent and showed a slight shaft fracture, though the device was removed intact.The procedure successfully completed with a 4.00 x 16mm synergy stent.No patient complications occurred, and the patient fully recovered.
Additional Manufacturer Narrative
Device analysis findings: the device was disposed of and therefore not returned for analysis; as a result, 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 performed for the agent dcb device confirmed that the event of shaft break is a known event defined in the products risk management 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.This code was selected as the most probable complaint cause based on the information available and the investigation conducted.Based on the event details it is possible that interactions of the balloon with the lesion's anatomical features, as well as interactions with the guide catheter contributed to the reported event.However, based on the information provided and the fact that no device was received for analysis, it is not possible to establish what the cause of the complaint was.It is likely that unintentional force was applied to the device during the repeated attempts to cross the target lesion which likely contributed to the hypotube bend and subsequently resulted in the slight fracture.
Event or Problem Description
It was reported that a shaft break occurred.The patient presented with coronary artery disease (cad).A 4.00 x 20 mm agent drug-coated balloon (dcb) was selected for percutaneous coronary intervention (pci).During treatment of the proximal circumflex, other devices such as the ivus catheter and pre-dilation balloons were able to cross the lesion without issue.After lesion preparation, the agent balloon could not be cross lesion and repeated attempts to deliver it caused the guide catheter to back out of the coronary artery multiple times.The hypotube became bent and showed a slight shaft fracture, though the device was removed intact.The procedure successfully completed with a 4.00 x 16mm synergy stent.No patient complications occurred, and the patient fully recovered.

• 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: 24474528
• Report Number: 2124215-2026-11162
• Device Sequence Number: 9615969
• Product Code: OOB
• UDI-Device Identifier: 00191506014841
• UDI-Public: (01)00191506014841(17)260911(10)9317H24
• Combination Product (Y/N): Y
• Initial Reporter State: SC
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/26/2026

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: 09/11/2026
• Device Model Number: H7493960820400
• Device Catalogue Number: H7493960820400
• Device Lot Number: 09317H24
• 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: 02/04/2026
• Supplement Date Received by Manufacturer: 03/20/2026
• Initial Report FDA Received Date: 02/27/2026
• Supplement Report FDA Received Date: 03/26/2026
• Date Device Manufactured: 09/11/2024
• 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