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

Model Number	2760
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/01/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
B3 date of event was estimated based on the initial notification date as the event date was not reported.The device was returned for analysis.Visual inspection revealed the gauge needle was at 10 atm when received and was unable to be returned to 0.The device presented a contrast media in the tube.Functional testing could not be performed due to the device was unable to be returned to 0.
Event or Problem Description
It was reported that a device issue occurred.An encore 26 advantage kit was selected for use.During the procedure, it was noted that the inflator was unable to function properly.No patient complications were reported.However, device analysis revealed the gauge could not zero.
Additional Manufacturer Narrative
B5 describe event and problem and g3 bsc aware date: corrected.B3 date of event was estimated based on the initial notification date as the event date was not reported.The device was returned for analysis.Visual inspection revealed the gauge needle was at 10 atm when received and was unable to be returned to 0.The device presented a contrast media in the tube.Functional testing could not be performed due to the device was unable to be returned to 0.
Event or Problem Description
Reportable based on device analysis completed on 30nov2023.It was reported that a device issue occurred.An encore 26 advantage kit was selected for use.During the procedure, it was noted that the inflator was unable to function properly.No patient complications were reported.However, device analysis revealed the gauge could not zero.The device was returned for analysis.Visual inspection revealed the gauge needle was at 10 atm when received and was unable to be returned to 0.The device presented a contrast media in the tube.Functional testing could not be performed due to the device was unable to be returned to 0.

• 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
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; model farm road; cork ; EI
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 18261099
• Report Number: 2124215-2023-68580
• Device Sequence Number: 3893722
• 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): 12/08/2023

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: 01/26/2025
• Device Model Number: 2760
• Device Catalogue Number: 2760
• Device Lot Number: 0030935604
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/20/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 11/30/2023
• Initial Report FDA Received Date: 12/04/2023
• Supplement Report FDA Received Date: 12/08/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/27/2023
• 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