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

Model Number	25335
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	12/01/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
B3 date of event: date of event was approximated to (b)(6) /2023 as no event date was reported.
Event or Problem Description
It was reported that a foreign material was present in the device.An encore 26 inflation device was selected for use.During preparation, it was noted that the device contained what appears to be a hair.The procedure was completed with another of the same device.No patient injury reported.
Additional Manufacturer Narrative
B3 date of event: date of event was approximated to 12/01/2023 as no event date was reported.The device was returned for analysis.Visual inspection revealed no sign of hair or any silicon droplet.
Event or Problem Description
It was reported that a foreign material was present in the device.An encore 26 inflation device was selected for use.During preparation, it was noted that the device contained what appears to be a hair.The procedure was completed with another of the same device.No patient injury reported.

• Brand Name: ENCORE 26
• 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: 18410433
• Report Number: 2124215-2023-74180
• Device Sequence Number: 8723515
• Product Code: MAV
• UDI-Device Identifier: 08714729183624
• UDI-Public: 08714729183624
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K955869
• 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,Followup
• Report Date (Section B): 01/31/2024

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: 06/29/2025
• Device Model Number: 25335
• Device Catalogue Number: 25335
• Device Lot Number: 0031930241
• 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: 12/14/2023
• Supplement Date Received by Manufacturer: 01/19/2024
• Initial Report FDA Received Date: 12/28/2023
• Supplement Report FDA Received Date: 01/31/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/30/2023
• 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