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

Model Number	H7493960820250
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Codes	Low Blood Pressure/ Hypotension (1914); Ischemia (1942)
Date of Event	05/28/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that ischemia and hypotension occurred.A 2.50 x 20 mm agent drug-coated balloon (dcb) was selected for use.Aggressive pre-dilatation was performed for in-stent restenosis (isr) at the ostial circumflex, left anterior descending artery (lad), and left main bifurcation using nc emerge and non-boston scientific balloons.The device was prepared according to standard protocol.During attempted delivery to the ostial circumflex, the agent balloon encountered resistance and failed to cross easily.Multiple attempts with deep guide engagement led to ischemia.The balloon was eventually successfully advanced and inflated; however, after 30 seconds of inflation, the patient developed severe hypotension, requiring administration of neo-synephrine (neo), deflation of the agent balloon, and disengagement of the guide catheter.Further neo-synephrine was administered, and the patient was instructed to cough to mitigate the risk of cardiac arrest.After 20 seconds, the hypotension resolved, and the procedure was successfully completed without further complications.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: 22299034
• Report Number: 2124215-2025-40360
• Device Sequence Number: 9227719
• Product Code: OOB
• UDI-Device Identifier: 00191506014803
• UDI-Public: (01)00191506014803(17)260419(10)2988H24
• Combination Product (Y/N): Y
• Initial Reporter State: NY
• 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
• Report Date (Section B): 06/20/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/19/2026
• Device Model Number: H7493960820250
• Device Catalogue Number: H7493960820250
• Device Lot Number: 02988H24
• 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: 05/28/2025
• Initial Report FDA Received Date: 06/20/2025
• Date Device Manufactured: 04/19/2024
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown