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

Model Number	H7493960830300
Medical Device Problem Codes	Inflation Problem (1310); Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/05/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the balloon had a hole.The 60% stenosed lesion was located in a mildly tortuous lesion.A 3.00 mm x 30.00 mm agent drug-coated balloon (dcb) was selected for percutaneous coronary intervention (pci), along with vein graft anastomosis, to treat in-stent restenosis (isr).No damage was observed during device unpacking or preparation, and the device advanced smoothly over the wire and through the guide catheter without difficulty.The balloon was prepared and advanced over the guidewire; however, it failed to maintain pressure during inflation due to a hole in the balloon.The procedure was successfully completed with another balloon and there was no patient complication.
Additional Manufacturer Narrative
Device evaluated by manufacturer: agent dcb returned for analysis.Visual, tactile, microscopic analysis and leakage testing was performed on the device.A visual inspection of the outer and inner lumen and tactile examination of the entire extrusion identified that there were tears in the midshaft 30.2cm and 30.8cm from the distal tip.No damage was observed to the midshaft itself which could have contributed to the tears.Microscopic examination of the midshaft itself identified no damage or scratches which could have contributed to the tears.A detailed microscopic examination of the balloon material identified no tears or pinholes in the balloon.An attempt to inflate the balloon could not be performed due to the damage observed in the midshaft.Bumper tip showed no signs of distal tip damage.Inspection of the remainder of the device, revealed no other damage or irregularities.
Event or Problem Description
It was reported that the balloon had a hole.The 60% stenosed lesion was located in a mildly tortuous lesion.A 3.00 mm x 30.00 mm agent drug-coated balloon (dcb) was selected for percutaneous coronary intervention (pci), along with vein graft anastomosis, to treat in-stent restenosis (isr).No damage was observed during device unpacking or preparation, and the device advanced smoothly over the wire and through the guide catheter without difficulty.The balloon was prepared and advanced over the guidewire; however, it failed to maintain pressure during inflation due to a hole in the balloon.The procedure was successfully completed with another balloon and there was no patient complication.

• 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: 22916488
• Report Number: 2124215-2025-60704
• Device Sequence Number: 21277938
• Product Code: OOB
• UDI-Device Identifier: 00191506014896
• UDI-Public: (01)00191506014896(17)260423(10)3818H24
• Combination Product (Y/N): Y
• Initial Reporter State: CA
• 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): 10/13/2025

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: 04/23/2026
• Device Model Number: H7493960830300
• Device Catalogue Number: H7493960830300
• Device Lot Number: 03818H24
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/25/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/06/2025
• Supplement Date Received by Manufacturer: 09/18/2025
• Initial Report FDA Received Date: 08/28/2025
• Supplement Report FDA Received Date: 10/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/23/2024
• 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