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

Model Number	H7493960830300
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/01/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the shaft break occurred.The patient presented with coronary artery disease (cad).A 3.00 x 30mm agent drug-coated balloon (dcb) was selected for percutaneous coronary intervention (pci).It was noted that the delivery shaft broke and the procedure was successfully completed with another device.There was no patient complications reported.
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.Detailed product information was not provided to bsc.We completed a good faith effort to obtain the information, but it was unable to be obtained.
Event or Problem Description
It was reported that the shaft break occurred.The patient presented with coronary artery disease (cad).A 3.00 x 30mm agent drug-coated balloon (dcb) was selected for percutaneous coronary intervention (pci).It was noted that the delivery shaft broke and the procedure was successfully completed with another device.There was no patient complications reported.
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.The device was not returned for analysis.However, media inspection revealed a visible break in the hypotube shaft.The provided image captured only one side of the damage.Media inspection confirmed the reported allegation.Detailed product information was not provided to bsc.We completed a good faith effort to obtain the information, but it was unable to be obtained.

• 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: 23316983
• Report Number: 2124215-2025-73986
• Device Sequence Number: 17385425
• Product Code: OOB
• UDI-Device Identifier: 00191506014896
• UDI-Public: (01)00191506014896(17)260626(10)6526H24
• 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): 12/15/2025

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: 06/26/2026
• Device Model Number: H7493960830300
• Device Catalogue Number: H7493960830300
• Device Lot Number: 06526H24
• 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: 09/24/2025
• Supplement Date Received by Manufacturer: 11/21/2025
• Initial Report FDA Received Date: 10/16/2025
• Supplement Report FDA Received Date: 12/15/2025
• Date Device Manufactured: 06/26/2024
• 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