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	04/13/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that there was foreign object in the device.An encore 26 inflation device was noted to have a white floating object inside.The procedure was completed with another of the same device.There was no patient involvement reported.
Event or Problem Description
It was reported that there was foreign object in the device.An encore 26 inflation device was noted to have a white floating object inside.The procedure was completed with another of the same device.There was no patient involvement reported.
Additional Manufacturer Narrative
Device evaluated by mfr: the device was returned for evaluation.Visual inspection revealed that there were no foreign materials were observed in the encore device.No other issues were identified during the product analysis.

• 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 CORK LIMITED; model farm road; cork ; EI
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 16872963
• Report Number: 2124215-2023-21007
• Device Sequence Number: 20322879
• 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: Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/10/2023

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: 01/09/2025
• Device Model Number: 25335
• Device Catalogue Number: 25335
• Device Lot Number: 0030820470
• 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: 04/13/2023
• Supplement Date Received by Manufacturer: 07/21/2023
• Initial Report FDA Received Date: 05/04/2023
• Supplement Report FDA Received Date: 08/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/10/2023
• 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