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

Model Number	3040
Medical Device Problem Codes	Break (1069); Display or Visual Feedback Problem (1184)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/01/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
B3.Used first day of the aware date as the event date was not reported.
Event or Problem Description
It was reported that the gauge was showing incorrect pressure.An encore 26 inflation device was selected for use.The encore device inflated the balloon even though the pressure gauge needle did not move.Additionally, a loose jingling sound was heard when the indeflator was moved which may indicate that there is a broken part within.The procedure was completed with another of the same device.There were no patient complications reported.
Event or Problem Description
It was reported that the gauge was showing incorrect pressure.An encore 26 inflation device was selected for use.The encore device inflated the balloon even though the pressure gauge needle did not move.Additionally, a loose jingling sound was heard when the indeflator was moved which may indicate that there is a broken part within.The procedure was completed with another of the same device.There were no patient complications reported.
Additional Manufacturer Narrative
B3.Used first day of the aware date as the event date was not reported.Device evaluated by manufacturer: the device was returned for analysis.A visual and functional analysis were performed on the device.The gauge needle was at 0 atm when received.The device does not have visual defects.The unit passed all functional tests without issues.

• 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 CORK LIMITED; model farm road; cork T12 Y K88; EI T12 YK88
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 18389169
• Report Number: 2124215-2023-69753
• Device Sequence Number: 3967468
• Product Code: MAV
• UDI-Device Identifier: 08714729177029
• UDI-Public: 08714729177029
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/16/2024

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: 06/27/2025
• Device Model Number: 3040
• Device Catalogue Number: 3040
• Device Lot Number: 0031913176
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/04/2023
• Supplement Date Received by Manufacturer: 01/23/2024
• Initial Report FDA Received Date: 12/22/2023
• Supplement Report FDA Received Date: 02/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/28/2023
• 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