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

Model Number	2760
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/08/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluated by manufacturer: the device was returned for analysis.Visual inspection was performed.The gauge needle could not be returned to zero, confirming the reported event.No further visual issues were noted with the device.Further functional testing could not be performed because the gauge needle could not be returned to zero.
Event or Problem Description
Reportable based on device analysis completed on (b)(6) 2023.It was reported that the gauge needle of the indeflator has been shaken off.A 26 0452701 advantage was selected for use.During the procedure, the gauge needle has been shaken off and did not return to its original state.The procedure was completed with another of the same device.No patient complications were reported.However, device analysis revealed that the needle was unable to be returned to zero.

• 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 CORK LIMITED; EI
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 18357765
• Report Number: 2124215-2023-71227
• Device Sequence Number: 6594286
• Product Code: MAV
• UDI-Device Identifier: 08714729180005
• UDI-Public: 08714729180005
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Other,Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/19/2023

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 Model Number: 2760
• Device Catalogue Number: 2760
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/28/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/29/2023
• Initial Report FDA Received Date: 12/19/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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