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

Model Number	H7493960820250
Medical Device Problem Codes	Break (1069); Deformation Due to Compressive Stress (2889)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/05/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Good faith effort attempts were made to try and retrieve additional details regarding the reported event, but further information was unable to be obtained.
Event or Problem Description
It was reported that the device broke off towards the hub.The 70% stenosed target lesion was located in the severely tortuous, moderately calcified distal right coronary artery (rca).During the procedure, a 2.50 mm x 20.00 mm agent drug-coated balloon (dcb) was selected for treatment.During the procedure, while advancing the balloon and trying to cross the lesion, the shaft broke off towards the hub.The device was removed from the patient without complication.The procedure was successfully completed with a different device.There was no patient complication, and the patient was in good condition after the procedure.
Additional Manufacturer Narrative
Device evaluated by manufacturer: the device was returned for analysis.Visual, tactile and microscopic analysis was performed on the device.A break was identified 23cm distal to the distal end of the strain relief with multiple kinks along the hypotube shaft.No other device issues were identified during returned product analysis.Good faith effort attempts were made to try and retrieve additional details regarding the reported event, but further information was unable to be obtained.
Event or Problem Description
It was reported that the device broke off towards the hub.The 70% stenosed target lesion was located in the severely tortuous, moderately calcified distal right coronary artery (rca).During the procedure, a 2.50 mm x 20.00 mm agent drug-coated balloon (dcb) was selected for treatment.During the procedure, while advancing the balloon and trying to cross the lesion, the shaft broke off and was kinked towards the hub.The device was removed from the patient without complication.The procedure was successfully completed with a different device.There was no patient complication, and the patient was in good condition after the procedure.

• 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: 23821677
• Report Number: 2124215-2025-91211
• Device Sequence Number: 15790229
• Product Code: OOB
• UDI-Device Identifier: 00191506014803
• UDI-Public: (01)00191506014803(17)260709(10)6946H24
• Combination Product (Y/N): Y
• Initial Reporter State: PA
• 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): 01/29/2026

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: 07/09/2026
• Device Model Number: H7493960820250
• Device Catalogue Number: H7493960820250
• Device Lot Number: 06946H24
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/10/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/20/2025
• Supplement Date Received by Manufacturer: 01/07/2026
• Initial Report FDA Received Date: 12/16/2025
• Supplement Report FDA Received Date: 01/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/09/2024
• 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