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

Model Number	CEK-1866-20
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	08/09/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block d4 and h4: the complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.However, the complainant reported that the device was not expired.Block h6: imdrf device code a1802 captures the reportable event of device package contains foreign matter.
Event or Problem Description
It was reported to boston scientific corporation that a compliance endokit was opened on (b)(6) 2024 during preparation for a procedure.Upon opening the package, a hair was found inside the kit.Another compliance kit was used for the procedure.There was no reported patient complications associated with this event.
Additional Manufacturer Narrative
Block h2: block d4 lot number has been updated with additional information received on september 23, 2024.Block h6: imdrf device code a1802 captures the reportable event of device package contains foreign matter.Block h11: additional information: block d4 lot number has been updated based on the additional information provided.
Event or Problem Description
It was reported to boston scientific corporation that a compliance endokit was opened on (b)(6) 2024 during preparation for a procedure.Upon opening the package, a hair was found inside the kit.Another compliance kit was used for the procedure.There was no reported patient complications associated with this event.
Additional Manufacturer Narrative
Block h2: block d4 lot number has been updated with additional information received on (b)(6) 2024.Block h6: imdrf device code a1802 captures the reportable event of device package contains foreign matter.Block h10: investigation results the returned compliance endokit was analyzed.Visual evaluation found that a single hair strand.No other problems were noted.The reported event was confirmed.The foreign material was found in the device packaging between the cinchpad and the outer wrap.It is possible that the problem can be traced to the failure to maintain or establish techniques for controlling and verifying the product specifications including implied but undocumented specifications.Based on all available information and analysis of the returned device, the most probable cause is quality control deficiency.Block h11: additional information: block d4 lot number has been updated based on the additional information provided.
Event or Problem Description
It was reported to boston scientific corporation that a compliance endokit was opened on (b)(6) 2024.Upon opening the package, a hair was found inside the kit.There was no patient involvement with this event.

• Brand Name: COMPLIANCE ENDOKIT
• 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; 11810 wills road; alpharetta GA 30009
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 20135140
• Report Number: 3005099803-2024-04205
• Device Sequence Number: 20657088
• Product Code: MNL
• UDI-Device Identifier: 00191506034726
• UDI-Public: 00191506034726
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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,Followup,Followup
• Report Date (Section B): 11/20/2024

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: 03/31/2026
• Device Model Number: CEK-1866-20
• Device Catalogue Number: 2088-21
• Device Lot Number: 0034330332
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/09/2024
• Supplement Date Received by Manufacturer: 09/23/2024; 10/31/2024
• Initial Report FDA Received Date: 09/04/2024
• Supplement Report FDA Received Date: 10/15/2024; 11/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/13/2024
• 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