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

Model Number	2800
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/11/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that foreign material was observed on the device.Following opening of the package, a black hair was noted on the encore 26 locking button.The device was not used.The procedure was completed with a replacement device and no patient complications were reported.
Additional Manufacturer Narrative
The returned product consisted of the encore ic device.The device was returned with its original pouch and overall visual review did not identify failures or evidence that could be lost due to decontamination process.The gauge needle was at 0 atm when received.There was no visual evidence of a black hair on the yellow button of the device.Based on the device investigation, the reported event could not be confirmed.
Event or Problem Description
It was reported that foreign material was observed on the device.Following opening of the package, a black hair was noted on the encore 26 locking button.The device was not used.The procedure was completed with a replacement device and no patient complications were reported.

• 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 T12 Y K88; EI T12 YK88
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 18619446
• Report Number: 2124215-2024-05460
• Device Sequence Number: 19434422
• Product Code: MAV
• UDI-Device Identifier: 08714729127048
• UDI-Public: 08714729127048
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/12/2024

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: 09/20/2025
• Device Model Number: 2800
• Device Catalogue Number: 2800
• Device Lot Number: 0032474440
• 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: 01/11/2024
• Supplement Date Received by Manufacturer: 03/11/2024
• Initial Report FDA Received Date: 01/31/2024
• Supplement Report FDA Received Date: 03/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/21/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown