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

Model Number	H7493960812300
Medical Device Problem Codes	Break (1069); Entrapment of Device (1212); Use of Device Problem (1670); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/27/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that catheter froze on wire occurred.A 3.00 x 12mm agent dcb balloon was selected for percutaneous coronary intervention procedure to treat coronary artery disease and in-stent restenosis.During the procedure, when the physician advanced the balloon, it was not noted that the balloon protector was still on the device.The cover would not advance through the touhy.The physician tried to peel away the cover while the device was on the guidewire but was not successful.The cover had been pushed to the monorail exit port of the balloon and the balloon was stuck on the guidewire.During attempts to remove the balloon from the guidewire outside the patient, the balloon monorail/hypotube broke away from the shaft and the guidewire also snapped.The procedure was completed using a new guidewire and a new agent balloon.No patient complications were reported.
Event or Problem Description
It was reported that catheter froze on wire occurred.A 3.00 x 12mm agent dcb balloon was selected for percutaneous coronary intervention procedure to treat coronary artery disease and in-stent restenosis.During the procedure, when the physician advanced the balloon, it was not noted that the balloon protector was still on the device.The cover would not advance through the touhy.The physician tried to peel away the cover while the device was on the guidewire but was not successful.The cover had been pushed to the monorail exit port of the balloon and the balloon was stuck on the guidewire.During attempts to remove the balloon from the guidewire outside the patient, the balloon monorail/hypotube broke away from the shaft and the guidewire also snapped.The procedure was completed using a new guidewire and a new agent balloon.No patient complications were reported.
Additional Manufacturer Narrative
Device evaluated by manufacturer: the returned product consisted of the agent dcb mr 3.00 mm x 12.00 mm balloon catheter, batch 06612h24.Visual, tactile and microscopic analysis was performed on the device.Examination of the mid-shaft and inner wire lumen sections noted a break in the midshaft at 28cm from the distal tip and the inner lumen was accordioned.In addition, multiple hypotube kinks were noted.No other device issues were identified during returned product analysis.Media/photo were provided for review, which show evidence of the break in the midshaft.Device analysis confirmed the complaint allegation of shaft break.

• 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: 21876972
• Report Number: 2124215-2025-23946
• Device Sequence Number: 18072263
• Product Code: OOB
• UDI-Device Identifier: 00191506014681
• UDI-Public: (01)00191506014681(17)260628(10)6612H24
• Combination Product (Y/N): Y
• Initial Reporter State: FL
• 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): 06/24/2025

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: 06/28/2026
• Device Model Number: H7493960812300
• Device Catalogue Number: H7493960812300
• Device Lot Number: 06612H24
• 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: 03/27/2025
• Supplement Date Received by Manufacturer: 05/30/2025
• Initial Report FDA Received Date: 04/21/2025
• Supplement Report FDA Received Date: 06/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/28/2024
• 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