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

Model Number	SBD-289-50
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/26/2026
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 e1: the event was reported by the scope tech; however, their contact information is unavailable.Healthcare facility name: (b)(6).Block h6: imdrf device code a0401 is being used to capture 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) 2026.During cleaning, the brush catheter snapped in half at the midpoint of the scope.There was no resistance during brushing, and the tubing showed no kinks or bends.The remaining portion of the catheter was successfully removed from the scope.A new brush of the same device type was used to complete the cleaning process.No patient was present at the time of the event, and no patient complications occurred.

• 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: 24690016
• Report Number: 3005099803-2026-01094
• Device Sequence Number: 9706594
• Product Code: MNL
• UDI-Device Identifier: 00816849010090
• UDI-Public: (01)00816849010090
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/19/2026

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-289-50
• Device Catalogue Number: 60252
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/26/2026
• Supplement Date Received by Manufacturer: 04/24/2026
• Initial Report FDA Received Date: 03/25/2026
• Supplement Report FDA Received Date: 05/19/2026
• 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