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

Model Number	H7493960830250
Medical Device Problem Codes	Material Rupture (1546); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/09/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon ruptured.A 2.50 mm x 30.00 mm agent drug-coated balloon (dcb) was selected for treatment of in-stent restenosis (isr).During procedure, on inflating, it was noted that the balloon ruptured at 6atm.The procedure was completed with alternate device and there was no patient complication.
Event or Problem Description
It was reported that balloon ruptured.A 2.50 mm x 30.00 mm agent drug-coated balloon (dcb) was selected for treatment of in-stent restenosis (isr).During procedure, on inflating, it was noted that the balloon ruptured at 6atm.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 2.50 x 30mm balloon catheter, batch 03438h24.A visual and tactile examination identified multiple kinks along the length of the hypotube shaft.A detailed microscopic examination of the balloon material identified a 1mm longitudinal tear in the proximal section.Device analysis confirmed the complaint allegation of balloon material rupture.

• 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: 22382506
• Report Number: 2124215-2025-43917
• Device Sequence Number: 15791456
• Product Code: OOB
• UDI-Device Identifier: 00191506014872
• UDI-Public: (01)00191506014872(17)260425(10)3438H24
• 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,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: 04/25/2026
• Device Model Number: H7493960830250
• Device Catalogue Number: H7493960830250
• Device Lot Number: 03438H24
• 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: 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: 04/25/2024
• 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