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

Model Number	H7493960820250
Medical Device Problem Codes	Break (1069); Failure to Advance (2524); Deformation Due to Compressive Stress (2889)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/01/2026
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 2.50 mm x 20.00 mm agent drug-coated balloon (dcb) was selected for percutaneous coronary intervention (pci).During delivery, the agent balloon was unable to cross the lesion, and the hypotube bent and subsequently fractured.The device was removed without difficulty.A second 3.00 mm x 30 mm agent dcb was then advanced to a more proximal segment, but this device also failed to cross the lesion and the hypotube become significantly bent.It was also removed without incident.No patient complications, and the patient fully recovered.
Additional Manufacturer Narrative
B3: date of event: the event date was note reported.The first date of the month of the aware date was entered as an estimate.
Event or Problem Description
It was reported that a shaft break occurred.The patient presented with coronary artery disease (cad).A 2.50 mm x 20.00 mm agent drug-coated balloon (dcb) was selected for percutaneous coronary intervention (pci).During delivery, the agent balloon was unable to cross the lesion, and the hypotube bent and subsequently fractured.The device was removed without difficulty.A second 3.00 mm x 30 mm agent dcb was then advanced to a more proximal segment, but this device also failed to cross the lesion and the hypotube become significantly bent.It was also removed without incident.No patient complications, and the patient fully recovered.
Additional Manufacturer Narrative
B3: date of event: the event date was note reported.The first date of the month of the aware date was entered as an estimate.Device history 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.Device technical analysis: the device was not returned for analysis as it was disposed of at the healthcare facility (hcf); therefore, a technical analysis could not be performed on the device.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 performed for the agent dcb device confirmed that the event of 'shaft break' is a known event defined in the product's 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.' the device was not returned for analysis; the allegations cannot be confirmed.No image or procedural media was received from the customer.Additional information was requested from the customer regarding the reported event however, no new information was received and all information that was not provided was unknown.Based on the available information and considering that no device or media from the procedure was received, a clear conclusion for the reported events cannot be established.However, it is most likely that excessive handling and/or force was unintentionally applied to the device during the procedure which subsequently contributed to the reported kink and break.

• 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: 24474527
• Report Number: 2124215-2026-11151
• Device Sequence Number: 9615968
• Product Code: OOB
• UDI-Device Identifier: 00191506014803
• UDI-Public: (01)00191506014803
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/13/2026

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: H7493960820250
• Device Catalogue Number: H7493960820250
• 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: 03/06/2026
• Initial Report FDA Received Date: 02/27/2026
• Supplement Report FDA Received Date: 03/13/2026
• 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