MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION COMPLIANCE KIT; ACCESSORIES, CLEANING BRUSHES, FOR ENDOSCOPE

Model Number	CEK-2901-20
Medical Device Problem Code	Device Contaminated During Manufacture or Shipping (2969)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/13/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation that a compliance kit was opened on (b)(6), 2025 during preparation for a procedure.They found a bug or larva within the packaging of the kit.The procedure was completed using another of the same device.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block e1: the reported healthcare facility is: name of hcf: (b)(6) hospital.Address: (b)(6).Contact number: (b)(6).Block h6: imdrf device code a1802 captures the reportable event of device package contains foreign matter.

• Brand Name: COMPLIANCE KIT
• Common Device Name: ACCESSORIES, CLEANING BRUSHES, FOR ENDOSCOPE
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 11480 lakefield dr; johns creek GA 30097
• Manufacturer Contact: arlene acevedo gutierrez ; 300 boston scientific way; marlborough, MA 01752 ; 7877968283
• MDR Report Key: 22955327
• Report Number: 3005099803-2025-04498
• Device Sequence Number: 9591629
• Product Code: MNL
• UDI-Device Identifier: 00191506040659
• UDI-Public: (01)00191506040659(17)270401(10)36844697
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/03/2025

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 Model Number: CEK-2901-20
• Device Catalogue Number: 2088-28
• Device Lot Number: 0036844697
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/13/2025
• Initial Report FDA Received Date: 09/03/2025
• Date Device Manufactured: 04/14/2025
• 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