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

Model Number	25335
Medical Device Problem Codes	Display or Visual Feedback Problem (1184); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/09/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1 - initial reporter city: (b)(6).
Event or Problem Description
It was reported that the gauge was reading inaccurately, and the needle was sticking.The 90% stenosed target lesion was located in the moderately tortuous, non-calcified lateral cutaneous vein.An encore pi inflation device was used for treatment.During the procedure, the balloon was inflated under fluoroscopy.However, it was noted that the encore meter did not change from 0, the gauge needle was sticking and did not move.Despite the inaccurate gauge reading and needle sticking, the balloon itself did not fail to inflate.The procedure was completed with another of the same device.No patient complications were reported.

• Brand Name: ENCORE 26
• Common Device Name: SYRINGE, BALLOON INFLATION
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; model farm road; cork ; EI
• Manufacturer Contact: mark mischke ; 4100 hamline ave n; arden hills, MN 55112 ; 7634941632
• MDR Report Key: 22146950
• Report Number: 2124215-2025-35683
• Device Sequence Number: 20795693
• Product Code: MAV
• UDI-Device Identifier: 08714729183624
• UDI-Public: (01)08714729183624(17)270225(10)35933872
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K955869
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/04/2025

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: 25335
• Device Catalogue Number: 25335
• Device Lot Number: 0035933872
• 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: 05/12/2025
• Initial Report FDA Received Date: 06/04/2025
• Date Device Manufactured: 02/25/2025
• 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: BALLOON CATHETER - BRAVUS; GUIDEWIRE - FUGA
• Patient Sex: Unknown