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

Model Number	H7493960830250
Medical Device Problem Codes	Entrapment of Device (1212); Nonstandard Device (1420); Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/06/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the device froze on the wire.The patient presented with coronary artery disease (cad).The target lesion located in the calcified and tortuous coronary artery.A 2.50 mm x 30.00 mm agent drug-coated balloon (dcb) was selected for percutaneous coronary intervention (pci).During procedure, the agent became stuck on the wire and could not advance into the body.The procedure was successfully completed with another device.No patient complications were reported, and the patient fully recovered.
Additional Manufacturer Narrative
Device evaluated by manufacturer: a 2.50 x 30.00 mm agent dcb device was returned for analysis.Visual, tactile and microscopic analysis was performed on the device.A visual and tactile examination confirmed that a break existed in the mid shaft at 116.5 cm distal to the distal end of the strain relief.Additionally, corewire kinked 115.6cm distal to the distal end of the strain relief.The distal section of the device remained attached to a 0.014" guidewire and could not be removed.Microscopic examination identified stretching of the shaft polymer extrusion just distal to the exchange port.Further microscopic analysis confirmed that the distal section of the device, including the balloon profile, was severely stretched and bunched.Bumper tip showed no signs of distal tip damage.Inspection of the remainder of the device presented no other damage or irregularities.
Event or Problem Description
It was reported that the device froze on the wire.The patient presented with coronary artery disease (cad).The target lesion located in the calcified and tortuous coronary artery.A 2.50 mm x 30.00 mm agent drug-coated balloon (dcb) was selected for percutaneous coronary intervention (pci).During procedure, the agent became stuck on the wire and could not advance into the body.The procedure was successfully completed with another device.No patient complications were reported, 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: 23810886
• Report Number: 2124215-2025-90967
• Device Sequence Number: 21149780
• Product Code: OOB
• UDI-Device Identifier: 00191506014872
• UDI-Public: (01)00191506014872(17)260513(10)4522H24
• Combination Product (Y/N): Y
• Initial Reporter State: IA
• 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): 02/12/2026

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: 05/13/2026
• Device Model Number: H7493960830250
• Device Catalogue Number: H7493960830250
• Device Lot Number: 04522H24
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/21/2025
• Supplement Date Received by Manufacturer: 01/21/2026
• Initial Report FDA Received Date: 12/15/2025
• Supplement Report FDA Received Date: 02/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/13/2024
• 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