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

Model Number	2760
Medical Device Problem Code	Failure to Zero (1683)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/27/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the pressure did not return to the initial pressure (0 atm).An encore 26 advantage kit was selected for use.During the procedure, the device was inflated at 26 atm.Upon deflation, the balloon was in negative pressure, however, the manometer remained at a pressure of 26 atm and did not return to the initial pressure of 0 atm.No patient complications were reported.
Additional Manufacturer Narrative
Device evaluated by manufacturer: the device was returned for analysis.The gauge needle was at 24 atm when received.A non-transparent fluid (whitish) and thick was observed inside the syringe and in the flexing tube.Complete functional testing was not possible due to the obstruction in the flexing tube.A hard density material was observed inside the flexing tube & syringe upon x-ray inspection.
Event or Problem Description
It was reported that the pressure did not return to the initial pressure (0 atm).An encore 26 advantage kit was selected for use.During the procedure, the device was inflated at 26 atm.Upon deflation, the balloon was in negative pressure, however, the manometer remained at a pressure of 26 atm and did not return to the initial pressure of 0 atm.No patient complications were reported.

• 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: 15160282
• Report Number: 2124215-2022-28681
• Device Sequence Number: 6167854
• Product Code: MAV
• UDI-Device Identifier: 08714729180005
• UDI-Public: 08714729180005
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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,Followup
• Report Date (Section B): 01/20/2023

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: 01/10/2024
• Device Model Number: 2760
• Device Catalogue Number: 2760
• Device Lot Number: 0028652876
• 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: 07/14/2022
• Supplement Date Received by Manufacturer: 01/13/2023
• Initial Report FDA Received Date: 08/03/2022
• Supplement Report FDA Received Date: 01/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/10/2022
• 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