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

Model Number	H7493960830400
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/11/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the balloon burst.An agent us mr 4.00 x 30mm was selected for treatment of the target lesion, which was located in the right coronary artery (rca).During the procedure, the physician inflated the balloon to 11atm when a loss of pressure was noted in the inflation device.The device was pulled, and the balloon was noted to have ruptured.The balloon was removed from the patient and another similar device was used to successfully complete the procedure.There were no patient complications.
Event or Problem Description
It was reported that the balloon burst.An agent us mr 4.00 x 30mm was selected for treatment of the target lesion, which was located in the right coronary artery (rca).During the procedure, the physician inflated the balloon to 11atm when a loss of pressure was noted in the inflation device.The device was pulled, and the balloon was noted to have ruptured.The balloon was removed from the patient and another similar device was used to successfully complete the procedure.There were no patient complications.
Additional Manufacturer Narrative
Returned product consisted of the agent device.A visual inspection of the device revealed no damages or defects.A microscopic analysis showed a pinhole leak 6mm proximal to the distal markerband.The pinhole leak was further confirmed during a functional test.Based on the event description it is likely that the balloon damage occurred due to interaction with potentially challenging lesion conditions or through interaction with ancillary devices.Because of this, the investigation is assigned a most probable investigation conclusion code of adverse event related to procedure.

• 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: 21105117
• Report Number: 2124215-2024-83109
• Device Sequence Number: 8023136
• Product Code: OOB
• UDI-Device Identifier: 00191506014919
• UDI-Public: 00191506014919
• Combination Product (Y/N): Y
• Initial Reporter State: GA
• 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): 02/21/2025

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: 08/23/2026
• Device Model Number: H7493960830400
• Device Catalogue Number: H7493960830400
• Device Lot Number: 08690H24
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/02/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/11/2024
• Supplement Date Received by Manufacturer: 01/28/2025
• Initial Report FDA Received Date: 01/08/2025
• Supplement Report FDA Received Date: 02/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/23/2024
• 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