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	10/05/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that foreign matter was found.A hair was noted to be sealed inside the unopened sterile packaging of an encore 26 advantage inflation device.The device was discarded.

• 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
• MDR Report Key: 12623689
• Report Number: 2134265-2021-12812
• Device Sequence Number: 16494379
• Product Code: MAV
• UDI-Device Identifier: 08714729127048
• UDI-Public: 08714729127048
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• 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: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/13/2021

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: 04/13/2023
• Device Model Number: 2800
• Device Catalogue Number: 2800
• Device Lot Number: 0027133235
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/05/2021
• Initial Report FDA Received Date: 10/13/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1