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

Model Number	SBD-289-50
Medical Device Problem Codes	Break (1069); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/25/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block d4: this is a non-sterile device with no expiration date.Block d4, h4: the complainant was unable to provide a lot number.Therefore, the manufacture date is unknown.Block h6: imdrf device code a0401 captures the reportable event of brush break.
Event or Problem Description
It was reported to boston scientific corporation that a hedgehog double-end brush was used during scope cleaning on (b)(6) 2025.During scope cleaning, the bristles of the brush were lost.The scope cleaning was completed with a different device.There was no patient involvement in this event.
Additional Manufacturer Narrative
Block d4: this is a non-sterile device with no expiration date.Block d4, h4: the complainant was unable to provide a lot number.Therefore, the manufacture date is unknown.Block h6: imdrf device code a0401 captures the reportable event of brush break.Block h11: investigation results the returned hedgehog dual-end brush was analyzed.Both ends showed clear evidence of extensive use.The valve end bristles were found to be deformed, while several rows of bristles on the channel-end were detached.No other problems were noted.The reported event was confirmed.The damage observed suggests heavy usage and twisting forces.It is likely that the interaction between the brush and the scope led to the bristle detachment and deformation.The device instructions for use (dfu) caution against applying excessive force or torque, specifically advising: do not twist the channel brush while the brush is in the scope and valve brushes: avoid twisting or torquing the brush handle.Based on all gathered information, the probable cause was determined to be unintended use error caused or contributed to event, indicating that the interaction between the user and device, caused or contributed to the event.
Event or Problem Description
It was reported to boston scientific corporation that a hedgehog double-end brush was used during scope cleaning on (b)(6) 2025.During scope cleaning, the bristles of the brush were lost.The scope cleaning was completed with a different device.There was no patient involvement in this event.

• Brand Name: HEDGEHOG
• Common Device Name: ACCESSORIES, CLEANING BRUSHES, FOR ENDOSCOPE
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): CHANGZHOU TEMEIRUI MEDICAL; building 34 no 249; middle liangchan; changzhou, 100 21320 0; CH 213200
• Manufacturer Contact: christina lam ; 300 boston scientific way; marlborough, MA 01752 ; 9145716918
• MDR Report Key: 22543429
• Report Number: 3005099803-2025-03353
• Device Sequence Number: 20947045
• Product Code: MNL
• UDI-Device Identifier: 00816849010090
• UDI-Public: (01)00816849010090
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/12/2025

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: SBD-289-50
• Device Catalogue Number: 60252
• 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: 06/25/2025
• Supplement Date Received by Manufacturer: 10/22/2025
• Initial Report FDA Received Date: 07/18/2025
• Supplement Report FDA Received Date: 11/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown