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

Model Number	H7493960820400
Medical Device Problem Codes	Difficult to Remove (1528); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/17/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the ballon detached.The patient presented with in-stent restenosis (isr).The 80% stenosed target lesion was located in the mildly tortuous and mildly calcified left anterior descending artery (lad).A 4.00 mm x 30.00 mm agent drug-coated balloon (dcb) was selected for percutaneous coronary intervention (pci).No damage was observed during device unpacking or preparation, and the device advanced smoothly over the wire and through the guide catheter without difficulty.The balloon was inflated once at normal pressure for 60 seconds.During device withdrawal, the balloon detached from the shaft and became stuck within a non-boston scientific guiding catheter.The dislodged balloon was successfully removed using hemostats.The procedure was successfully completed with this device.There was no patient complication reported.
Additional Manufacturer Narrative
D4: lot number updated.Device evaluated by manufacturer: the agent dcb device was returned for analysis.Visual, tactile and microscopic analysis was performed on the device.During the visual and tactile inspection, multiple kinks were observed along the hypotube shaft.The balloon appeared to have been subjected to positive pressure and was returned in a deflated state.Microscopic analysis revealed no tears or pinholes in the balloon; however, the balloon had been pulled distally over the distal balloon cone, resulting in the tip being partially inverted and pulled into the distal end of the balloon.Examination of the shaft polymer extrusion profile showed a break at the port exchange, with severe stretching and kinking in the midshaft and distal polymer extrusion.The inner lumen had detached at the bicomponent bond with further stretching just distal to the detachment.A microscopic examination of the distal and proximal markerbands identified no damage.As a result of the severe stretching that was present in the inner lumen, the proximal markerband was positioned proximal to the proximal balloon sleeve.Inspection of the remainder of the device presented no other damage or irregularities.
Event or Problem Description
It was reported that the ballon detached.The patient presented with in-stent restenosis (isr).The 80% stenosed target lesion was located in the mildly tortuous and mildly calcified left anterior descending artery (lad).A 4.00 mm x 30.00 mm agent drug-coated balloon (dcb) was selected for percutaneous coronary intervention (pci).No damage was observed during device unpacking or preparation, and the device advanced smoothly over the wire and through the guide catheter without difficulty.The balloon was inflated once at normal pressure for 60 seconds.During device withdrawal, the balloon detached from the shaft and became stuck within a non-boston scientific guiding catheter.The dislodged balloon was successfully removed using hemostats.The procedure was successfully completed with this device.There was no patient complication reported.Initial reports indicated that a 4.00 mm x 30.00 mm agent drug-coated balloon (dcb) was selected for pci.However, additional information has been received that a 4.00 mm x 20.00 mm agent dcb was actually used.

• 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: 23267291
• Report Number: 2124215-2025-72129
• Device Sequence Number: 20163149
• Product Code: OOB
• UDI-Device Identifier: 00191506014919
• UDI-Public: (01)00191506014919(17)270312(10)2579H25
• Combination Product (Y/N): Y
• Initial Reporter State: CO
• 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): 11/12/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/19/2026
• Device Model Number: H7493960820400
• Device Catalogue Number: H7493960820400
• Device Lot Number: 01715H24
• 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: 09/17/2025
• Supplement Date Received by Manufacturer: 10/15/2025
• Initial Report FDA Received Date: 10/10/2025
• Supplement Report FDA Received Date: 11/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/20/2024
• 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: MEDTRONIC GUIDING CATHETER; MEDTRONIC GUIDING CATHETER
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown