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

Model Number	H7493960830250
Medical Device Problem Codes	Break (1069); Nonstandard Device (1420); Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/23/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the shaft broke.The target lesion, located in the left anterior descending artery (lad), was prepped with an nc emerge balloon.Intravascular ultrasound was not performed; however, the lad was assumed to be calcified as devices were difficult to track down the vessel.A 2.50 x 30 mm agent dcb was selected for use.When the device was connected to the inflation device, the shaft snapped off about 5 inches out from the back connection end.The procedure was cancelled and the patient was transferred to another facility for treatment of the complex lesion.
Additional Manufacturer Narrative
Good faith effort attempts were made to try and retrieve additional details regarding the reported event, but further information was unable to be obtained.
Event or Problem Description
It was reported that the shaft broke.The target lesion, located in the left anterior descending artery (lad), was prepped with an nc emerge balloon.Intravascular ultrasound was not performed, however, the lad was assumed to be calcified as devices were difficult to track down the vessel.A 2.50 x 30 mm agent dcb was selected for use.When the device was connected to the inflation device, the shaft snapped off about 5 inches out from the back connection end.The procedure was cancelled and the patient was transferred to another facility for treatment of the complex lesion.
Additional Manufacturer Narrative
Good faith effort attempts were made to try and retrieve additional details regarding the reported event, but further information was unable to be obtained.Device evaluated by manufacturer: the device was returned for analysis.Visual, tactile and microscopic analysis was performed on the device.A visual and tactile examination of the hypotube shaft identified multiple hypotube kinks.In addition, a break was noted at 20cm distal to the distal end of the strain relief.Microscopic examination of the outer and inner lumen noted stretching at 0.2cm distal to the bicomponent bond.No other device issues were identified during returned product analysis.
Additional Manufacturer Narrative
Good faith effort attempts were made to try and retrieve additional details regarding the reported event, but further information was unable to be obtained.
Event or Problem Description
It was reported that the shaft broke.The target lesion, located in the left anterior descending artery (lad), was prepped with an nc emerge balloon.Intravascular ultrasound was not performed, however, the lad was assumed to be calcified as devices were difficult to track down the vessel.A 2.50 x 30 mm agent dcb was selected for use.When the device was connected to the inflation device, the shaft snapped off about 5 inches out from the back connection end.The procedure was cancelled and the patient was transferred to another facility for treatment of the complex lesion.

• 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: 23587018
• Report Number: 2124215-2025-84344
• Device Sequence Number: 13144824
• Product Code: OOB
• UDI-Device Identifier: 00191506014872
• UDI-Public: (01)00191506014872
• 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,Followup
• Report Date (Section B): 01/14/2026

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: 07/29/2026
• Device Model Number: H7493960830250
• Device Catalogue Number: H7493960830250
• Device Lot Number: 07695H24
• 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: 10/24/2025
• Supplement Date Received by Manufacturer: 11/20/2025; 12/18/2025
• Initial Report FDA Received Date: 11/18/2025
• Supplement Report FDA Received Date: 12/17/2025; 01/14/2026
• Date Device Manufactured: 07/29/2024
• 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