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

Model Number	H7493960830200
Medical Device Problem Codes	Break (1069); Entrapment of Device (1212); Failure to Advance (2524)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/04/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that shaft break occurred.A 2.00 x 30mm agent balloon (bsc reference id# (b)(4) was selected for percutaneous coronary intervention procedure.The target lesion was located in the severely calcified distal left anterior descending artery (lad).Lesion was treated with 1.25 rotational atherectomy system and ballooning was performed which adequately prepped vessel.Upon attempted delivery of the agent balloon to the distal lad, balloon could not be delivered to the treatment area.There was also lesion in mid lad, balloon was elected to be inflated, following inflation, balloon was stuck on non-bsc guidewire.An attempt was made to retrieve, the balloon was pulled back into the guide at which point it became more stuck on the wire and the shaft of the agent balloon broke.The wire was then removed which successfully removed agent balloon.Another a 2.00 x 30mm agent balloon (bsc reference id# (b)(4) was attempted to be delivered to the distal lad and a different non-bsc guidewire was used.The agent balloon was delivered over this guidewire but failed to reach the distal lad, the balloon was then used to treat another more proximal lesion.Upon removal, the agent balloon was stuck on the guidewire.Procedure was completed using a different device same model and no patient complications were reported.
Event or Problem Description
It was reported that shaft break occurred.A 2.00 x 30mm agent balloon was selected for percutaneous coronary intervention procedure.The target lesion was located in the severely calcified distal left anterior descending artery (lad).Lesion was treated with 1.25 rotational atherectomy system and ballooning was performed which adequately prepped vessel.Upon attempted delivery of the agent balloon to the distal lad, balloon could not be delivered to the treatment area.There was also lesion in mid lad, balloon was elected to be inflated, following inflation, balloon was stuck on non-bsc guidewire.An attempt was made to retrieve, the balloon was pulled back into the guide at which point it became more stuck on the wire and the shaft of the agent balloon broke.The wire was then removed which successfully removed agent balloon.Another a 2.00 x 30mm agent balloon was attempted to be delivered to the distal lad and a different non-bsc guidewire was used.The agent balloon was delivered over this guidewire but failed to reach the distal lad, the balloon was then used to treat another more proximal lesion.Upon removal, the agent balloon was stuck on the guidewire.Procedure was completed using a different device same model and no patient complications were reported.It was further reported that target lesion was 90% stenosed and located in mildly tortuous vessel.
Additional Manufacturer Narrative
B5 describe event or problem: updated.C2/d10 concomitant product/therapy: updated.

• 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: 21687127
• Report Number: 2124215-2025-18214
• Device Sequence Number: 9308734
• Product Code: OOB
• UDI-Device Identifier: 00191506014858
• UDI-Public: 00191506014858
• 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): 04/21/2025

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: 06/05/2026
• Device Model Number: H7493960830200
• Device Catalogue Number: H7493960830200
• Device Lot Number: 05442H24
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/04/2025
• Supplement Date Received by Manufacturer: 04/03/2025
• Initial Report FDA Received Date: 03/25/2025
• Supplement Report FDA Received Date: 04/21/2025
• Date Device Manufactured: 06/05/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: 7F EBU 3.5 LAUNCHER GUIDE CATHETER; NON-BSC GUIDEWIRE (SION BLUE); NON-BSC GUIDEWIRE (SION BLUE); UNKNOWN GUIDE
• Patient Sex: Unknown