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

Model Number	25375
Medical Device Problem Codes	Contamination (1120); Tear, Rip or Hole in Device Packaging (2385); Difficult to Open or Remove Packaging Material (2922)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/01/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that device contamination occurred.An encore 26 was selected for use.During preparation, difficulty opening an encore inflation syringe was noted.While attempting to open the packaging, the sterile paper tore and contaminated the product.The procedure was completed with another of the same device.No patient complications were reported.
Additional Manufacturer Narrative
The event date of (b)(6) 2023 is an estimated based of the aware date of (b)(6) 2023 as the exact date was not reported.
Additional Manufacturer Narrative
The event date of 01aug2023 is an estimated based of the aware date of 30aug2023 as the exact date was not reported.Device evaluated by mfr: the device was returned for evaluation.Visual inspection of the device revealed the device's packaging pouch was found torn.
Event or Problem Description
It was reported that device contamination occurred.An encore 26 was selected for use.During preparation, difficulty opening an encore inflation syringe was noted.While attempting to open the packaging, the sterile paper tore and contaminated the product.The procedure was completed with another of the same device.No patient complications were 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 CORK LIMITED; 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: 17802960
• Report Number: 2124215-2023-47751
• Device Sequence Number: 20628886
• Product Code: MAV
• UDI-Device Identifier: 08714729137542
• UDI-Public: 08714729137542
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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,Health Professional,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/29/2023

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: 05/08/2025
• Device Model Number: 25375
• Device Catalogue Number: 25375
• Device Lot Number: 0031582643
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 08/30/2023
• Supplement Date Received by Manufacturer: 11/10/2023
• Initial Report FDA Received Date: 09/22/2023
• Supplement Report FDA Received Date: 11/29/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/09/2023
• 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