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

Model Number	SBD-228-50
Medical Device Problem Codes	Difficult to Remove (1528); Material Integrity Problem (2978); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block b3 (date of event): date of event was approximated to 07/01/2025 as no event date was reported.Block d4, h4: the complainant was unable to report the lot number; therefore, the manufacture date is unknown.This is a non-sterile device with no expiration date.Block h6: imdrf device code a0401 captures the reportable investigation result of brush break.Block h11: the returned hedgehog was analyzed.The returned double end channel brush was missing one brush end.The detach brush was not returned.The catheter near the other end of the brush was kinked, and the brush was bent.The reported complaint of brush failure to remove was confirmed.The scope was not returned for analysis; therefore, the reported problem of scope damaged/defective was not confirmed.It likely the interaction between the cleaning brush and scope caused the observed failure.The directions for use (dfu) warns against excessive force/torque that may cause the brush head to detach from the working length.Based on all gathered information, the probable cause selected for brush failure to remove is unintended use error caused or contributed to the event, which indicates the interaction between the user and device, or sample, caused or contributed to the error.This includes unintended inappropriate use of the device and incorrect sample preparation.The scope was not returned for analysis, the most probable cause of the reported scope damaged/defective problem cannot be established due to lack of evidence.Therefore, the cause code selected is cause not established.
Event or Problem Description
It was reported to boston scientific corporation that a hedgehog double- end brush was used for scope cleaning after completing a procedure on an unknown date.During the scope cleaning, hedgehog brush became lodged near the forceps channel and could not be removed.The scope was subsequently sent to olympus for repair.There was no patient involvement in this event.Note: this complaint has been deemed mdr reportable based on the investigation result which revealed that there were brush bristles missing from both ends of the device.

• 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: 23413374
• Report Number: 3005099803-2025-05516
• Device Sequence Number: 12998289
• Product Code: MNL
• UDI-Device Identifier: 00816849010083
• UDI-Public: (01)00816849010083
• 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
• Report Date (Section B): 10/29/2025

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-228-50
• Device Catalogue Number: 60252
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/01/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/30/2025
• Initial Report FDA Received Date: 10/29/2025
• 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