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

Model Number	SBD-291-50
Medical Device Problem Codes	Break (1069); Difficult to Remove (1528); Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/22/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation that a hedgehog sweeper brush was used during scope cleaning performed on (b)(6) 2025.While cleaning the scope, the brush passed through the working channel without issue.However, during the second pass through the aspiration channel, resistance was encountered and removal became difficult.After the brush was fully withdrawn, its tip was found to be missing.The user then switched to a reusable metal brush.When the reusable brush passed through channel, the tip of the hedgehog brush was retrieved.The scope cleaning was completed using the reusable metal brush.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 head detached.
Event or Problem Description
It was reported to boston scientific corporation that a hedgehog sweeper brush was used during scope cleaning performed on (b)(6) 2025.While cleaning the scope, the brush passed through the working channel without issue.However, during the second pass through the aspiration channel, resistance was encountered and removal became difficult.After the brush was fully withdrawn, its tip was found to be missing.The user then switched to a reusable metal brush.When the reusable brush passed through channel, the tip of the hedgehog brush was retrieved.The scope cleaning was completed using the reusable metal brush.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 head detached.Block h11: investigation results the returned hedgehog sweeper brush was evaluated and found to have a break at the smaller end of the brush, while no damage was observed on the sweeper end.The analysis confirms the reported issues of brush head detachment, difficulty advancing the brush, and difficulty removing it.Based on the condition of the returned device it is evident that the customer experienced difficulties with advancing and removing the brush from the scope resulting in brush head detachment.It likely the interaction between the cleaning brush and scope caused the observed failure.A labeling review confirmed that instructions and warnings are present for the reported event.The instructions for use (ifu) cautions that excessive force or torque may cause the brush head to detach from the shaft.Based on all available information, the most probable cause was determined to be unintended use error caused or contributed to event which indicates that the way the user interacted with the device likely played a role, including improper handling or incorrect sample preparation.

• 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: 23607534
• Report Number: 3005099803-2025-06194
• Device Sequence Number: 9765553
• Product Code: MNL
• UDI-Device Identifier: 00816849016443
• UDI-Public: (01)00816849016443(11)250227(10)250226
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 05/04/2026

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-291-50
• Device Catalogue Number: 60252
• Device Lot Number: 0000250226
• 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: 10/29/2025
• Supplement Date Received by Manufacturer: 04/07/2026
• Initial Report FDA Received Date: 11/20/2025
• Supplement Report FDA Received Date: 05/04/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/27/2025
• 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