MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ENCORE 26 ADVANTAGE KIT; SYRINGE, BALLOON INFLATION

Model Number	H74904527011
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/30/2025
Type of Reportable Event	Malfunction
Event or Problem Description
In cathlab - equipment (indeflator) used during cath lab procedure was found to have debris floating inside cylinder.Cylinder is filled with a mix of saline and contrast, which did not contain this debris.Two indeflators were used and they both held debris which was black and white.The equipment had the same lot number.No harm to patient.

• Brand Name: ENCORE 26 ADVANTAGE KIT
• Common Device Name: SYRINGE, BALLOON INFLATION
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 21312220
• Report Number: 21312220
• Device Sequence Number: 15496001
• Product Code: MAV
• UDI-Device Identifier: 08714729180005
• UDI-Public: (01)08714729180005
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 02/03/2025
• Report Date (Section F): 02/03/2025

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 Model Number: H74904527011
• Device Catalogue Number: H74904527011
• Device Lot Number: 350665979
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Device Age: 3 MO
• Date Report to Manufacturer: 02/05/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/05/2025
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Date Report Sent to FDA: 02/03/2025