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

Model Number	H7493960820400
Medical Device Problem Codes	Break (1069); Nonstandard Device (1420)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/22/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a shaft break occurred.A 4.00 mm x 20.00 mm agent drug-coated balloon (dcb) was selected for treatment on a of the proximal circumflex.During the procedure, while advancing across the lesion, the shaft broke.The device was removed from the patient, and the procedure was completed with another drug coated balloon.There was no patient complication, and the patient fully recovered and was in good condition after the procedure.
Event or Problem Description
It was reported that a shaft break occurred.A 4.00 mm x 20.00 mm agent drug-coated balloon (dcb) was selected for treatment on a of the proximal circumflex.During the procedure, while advancing across the lesion, the shaft broke.The device was removed from the patient, and the procedure was completed with another drug coated balloon.There was no patient complication, and the patient fully recovered and was in good condition after the procedure.
Additional Manufacturer Narrative
Investigation results: device technical analysis: visual, tactile and microscopic analysis was performed on the device.Visual and tactile examination of the hypotube found a break at 24.3cm distal to the distal end of the strain relief.In addition, multiple hypotube kinks were identified.No other device issues were identified during returned product analysis.Device history review: it was confirmed that this device met manufacturing specification prior to distribution and there are no manufacturing deviations which could have contributed to the reported event.Labeling review: review of the instructions for use (ifu) confirmed there was relevant content and sufficient guidance with respect to the circumstances described within this complaint.No updates are required to the ifu as a result of this event.Based on the available information, there was no evidence of device off-label use, or failure to follow the instructions for use (ifu).Risk review: a risk review was performed, and it confirmed that the event was defined in the risk documentation.This event type has been accounted for during product risk analysis to support acceptable risk benefit for the product.Investigation conclusion: this investigation is assigned a most probable investigation conclusion code of cause not established.This code was selected as the most probable complaint cause based on the information available and the investigation conducted.The device was returned for product analysis.Visual and tactile examination of the hypotube found a break at 24.3cm distal to the distal end of the strain relief.In addition, multiple hypotube kinks were identified.No other device issues were identified.It is possible that unintentional force was applied to the device while advancing across the lesion which potentially contributed to the break and unreported kinks.However, based on the available complaint information and condition of the returned device, a definitive conclusion cannot be established with certainty.

• 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: 24378548
• Report Number: 2124215-2026-09104
• Device Sequence Number: 16004551
• Product Code: OOB
• UDI-Device Identifier: 00191506014841
• UDI-Public: (01)00191506014841(17)260719(10)7399H24
• Combination Product (Y/N): Y
• Initial Reporter State: RI
• 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): 04/17/2026

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: 07/19/2026
• Device Model Number: H7493960820400
• Device Catalogue Number: H7493960820400
• Device Lot Number: 07399H24
• 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: 01/22/2026
• Supplement Date Received by Manufacturer: 03/24/2026
• Initial Report FDA Received Date: 02/18/2026
• Supplement Report FDA Received Date: 04/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/19/2024
• 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
• Patient Sex: Unknown