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

Model Number	H7493960812300
Medical Device Problem Codes	Break (1069); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/06/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that shaft break occurred.A 3.00 x 12mm agent drug-coated balloon (dcb) was selected for percutaneous coronary intervention procedure.During procedure, balloon shaft broke.Device was removed out of patient and nothing was left in the patient.The procedure was completed with alternate device and there was no patient complication.
Additional Manufacturer Narrative
Device evaluated by manufacturer: the returned product consisted of the agent dcb mr 3.00 x 12mm balloon catheter, catheter batch 33127051.Visual, tactile and microscopic analysis was performed on the device.A visual and tactile examination of the hypotube found a break at 21.5cm distal to the distal end of the strain relief and multiple hypotube kinks.No other device issues were identified during returned product analysis.
Event or Problem Description
It was reported that shaft break occurred.A 3.00 x 12mm agent drug-coated balloon (dcb) was selected for percutaneous coronary intervention procedure.During procedure, balloon shaft broke.Device was removed out of patient and nothing was left in the patient.The procedure was completed with alternate device 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: 22383075
• Report Number: 2124215-2025-43921
• Device Sequence Number: 9075589
• Product Code: OOB
• UDI-Device Identifier: 00191506014681
• UDI-Public: (01)00191506014681(17)260628(10)6606H24
• Combination Product (Y/N): Y
• Initial Reporter State: IL
• 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): 08/07/2025

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: 06606H24
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/30/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/10/2025
• Supplement Date Received by Manufacturer: 08/01/2025
• Initial Report FDA Received Date: 07/02/2025
• Supplement Report FDA Received Date: 08/07/2025
• 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