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

Model Number	2760
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/29/2021
Type of Reportable Event	Malfunction
Event or Problem Description
Reportable based on device analysis completed on 14sep2022.It was reported that the pressure lost, and manometer was dysfunctional.An encore 26 advantage kit inflation device was selected for use.During the procedure, it was noted that the pressure was lost, and the manometer was dysfunctional.The procedure was completed, and no patient complications were reported.However, device analysis revealed that the gauge accuracy test was not able to complete due to loss of the needle to zero location.
Additional Manufacturer Narrative
Device evaluated by manufacturer: the encore ic was returned for analysis.A visual inspection was conducted.The gauge needle was at 20 atm when received.Functional inspection was conducted, the needle can move when increasing air pressure using the plunger and when releasing it gets back to 20 atm.A pressure damping test was conducted and the encore ic passed the test.A vacuum test was conducted, there was no bubble leakage observed.The encore ic passed side load testing.The encore ic gauge accuracy test was not able to be completed due to the loss of the needle zero location.

• Brand Name: ENCORE 26 ADVANTAGE KIT
• Common Device Name: SYRINGE, BALLOON INFLATION
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORK LIMITED; model farm road; cork ; EI
• Manufacturer Contact: jay johnson ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 15551286
• Report Number: 2134265-2022-08846
• Device Sequence Number: 19538408
• Product Code: MAV
• UDI-Device Identifier: 08714729180005
• UDI-Public: 08714729180005
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K140745
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/06/2022

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: 10/14/2023
• Device Model Number: 2760
• Device Catalogue Number: 2760
• Device Lot Number: 0028200298
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/24/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/14/2022
• Initial Report FDA Received Date: 10/06/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/14/2021
• 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