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

Model Number	SBB-382-50
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/18/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block d4: this is a non-sterile device with no expiration date.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 a scope cleaning, the tip of the brush detached and remained stuck in the forceps channel of the endoscope.The tip was retrieved using another cleaning brush and flushing with water.There was no patient involvement in this event.
Additional Manufacturer Narrative
Block d4: this is a non-sterile device with no expiration date.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.The returned brush found that the catheter had a clean break and a missing brush head, and no material defects or deformation were noted at the area where the device separated.No other visual damages were observed.The reported event was confirmed.It is possible that excessive force/torque caused the brush head to separate from the working length during cleaning.A labeling review confirmed that instructions and warnings are present for the reported event.According to the directions for use (dfu), excessive twisting or torquing is not recommended.Based on all available information and analysis of the returned device, the most probable cause is 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 a scope cleaning, the tip of the brush detached and remained stuck in the forceps channel of the endoscope.The tip was retrieved using another cleaning brush and flushing with water.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): BOSTON SCIENTIFIC CORPORATION; 11810 wills road; alpharetta GA 30009
• Manufacturer Contact: arlene acevedo gutierrez ; 300 boston scientific way; marlborough, MA 01752 ; 7877968283
• MDR Report Key: 21809113
• Report Number: 3005099803-2025-01548
• Device Sequence Number: 18342721
• Product Code: MNL
• UDI-Device Identifier: 00816849016900
• UDI-Public: (01)00816849016900
• 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,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/20/2025

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: SBB-382-50
• 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: 03/19/2025
• Supplement Date Received by Manufacturer: 07/30/2025
• Initial Report FDA Received Date: 04/09/2025
• Supplement Report FDA Received Date: 08/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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