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

Model Number	H7493960820250
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/01/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that device contamination occurred.The patient presented with in-stent restenosis.A 2.50 x 20 mm agent drug-coated balloon (dcb) was selected for use.It was noted that the device appeared dirty upon opening the box.The procedure successfully completed with another agent dcb.There was no patient complications reported.
Additional Manufacturer Narrative
B3: date of event: the event date was note reported.The first date of the month of the aware date was entered as an estimate.
Event or Problem Description
It was reported that device contamination occurred.The patient presented with in-stent restenosis.A 2.50 x 20 mm agent drug-coated balloon (dcb) was selected for use.It was noted that the device appeared dirty upon opening the box.The procedure successfully completed with another agent dcb.There was no patient complications reported.
Additional Manufacturer Narrative
Device evaluated by manufacturer: agent dcb returned for analysis.A visual, tactile and microscopic examination was performed.The device was received inserted through the protective coiled hoop.The hoop, with the device inside, was received in the opened outer box.An examination of the outer box identified no damage to the box.The inner pouch was not received for analysis.The blue closure strip had been opened.The balloon protector and mandrel had been removed from the device and was not received with the device for analysis.A microscopic of the plastic protective coiled hoop identified some traces/droplets of liquid.This liquid was consistent with water/saline.An examination of the balloon catheter identified no evidence of device used; however, there was evidence that some of the drug coating on the balloon was missing/dissolved.There was no dirt, or foreign material identified along the entire device.Inspection of the remainder of the device presented no other damage or irregularities.B3: date of event: the event date was note reported.The first date of the month of the aware date was entered as an estimate.

• 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: 22965121
• Report Number: 2124215-2025-62169
• Device Sequence Number: 13045769
• Product Code: OOB
• UDI-Device Identifier: 00191506014803
• UDI-Public: (01)00191506014803(17)260513(10)4512H24
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/07/2025

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: 05/13/2026
• Device Model Number: H7493960820250
• Device Catalogue Number: H7493960820250
• Device Lot Number: 04512H24
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/27/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/11/2025
• Supplement Date Received by Manufacturer: 10/17/2025
• Initial Report FDA Received Date: 09/04/2025
• Supplement Report FDA Received Date: 11/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/13/2024
• 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