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

Model Number	H7493960820300
Medical Device Problem Codes	Break (1069); Failure to Advance (2524)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/28/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the shaft separation occurred.The 60% stenosed target lesion was located in the mildly tortuous and moderately calcified proximal left anterior descending (lad).A 3.00 x 20mm agent drug-coated balloon (dcb) was selected for left heart catheterization (lhc).The target lesion properly prepared with non-boston scientific intravascular lithotripsy (ivl) and intravascular ultrasound (ivus).When the catheter was advanced and positioned proximal to the lesion, the catheter unable to cross the lesion, and the shaft broke.The physician was removed the device in one piece without any problems.The procedure completed with another agent dcb and there was no patient complication reported.
Event or Problem Description
It was reported that the shaft separation occurred.The 60% stenosed target lesion was located in the mildly tortuous and moderately calcified proximal left anterior descending (lad).A 3.00 x 20mm agent drug-coated balloon (dcb) was selected for left heart catheterization (lhc).The target lesion properly prepared with non-boston scientific intravascular lithotripsy (ivl) and intravascular ultrasound (ivus).When the catheter was advanced and positioned proximal to the lesion, the catheter unable to cross the lesion, and the shaft broke.The physician was removed the device in one piece without any problems.The procedure completed with another agent dcb and there was no patient complication reported.
Additional Manufacturer Narrative
Device evaluated by manufacturer: visual, tactile and microscopic analysis was performed on the device.A visual and tactile examination of the hypotube shaft identified multiple hypotube kinks along the length of the shaft but the reported shaft break/separation was not detected.A visual inspection of the outer and inner lumen and tactile examination of the entire extrusion found no issues.A detailed microscopic examination of the balloon material identified no tears or pinholes in the balloon.Bumper tip showed no signs of distal tip damage.Inspection of the remainder of the device presented no other damage or irregularities.Device analysis unable to confirm the reported event, as there was no break present.

• 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: 21677962
• Report Number: 2124215-2025-17305
• Device Sequence Number: 12849343
• Product Code: OOB
• UDI-Device Identifier: 00191506014827
• UDI-Public: (01)00191506014827(17)260201(10)1085H24
• Combination Product (Y/N): Y
• Initial Reporter State: IL
• 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): 05/15/2025

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: 02/01/2026
• Device Model Number: H7493960820300
• Device Catalogue Number: H7493960820300
• Device Lot Number: 01085H24
• 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: 02/28/2025
• Supplement Date Received by Manufacturer: 04/23/2025
• Initial Report FDA Received Date: 03/24/2025
• Supplement Report FDA Received Date: 05/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/02/2024
• 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