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

Model Number	SBD-228-50
Medical Device Problem Codes	Break (1069); Entrapment of Device (1212)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/01/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Note: this report pertains to the one hedgehog double-end brush used during scope cleaning and prior procedure retained in the scope.Refer to manufacturer report# for the hedgehog double-end brush (device malfunction report) and 3005099803-2025-02767 for the hedgehog double-end brush.(serious injury report) it was reported to boston scientific corporation that a hedgehog double-end brush was used during a scope cleaning on (b)(6) 2025.During scope cleaning, the tip of the brush broke off and remained lodged inside the bronchoscope.The tech was cleaning and did not notice the broken brush until the reprocessing was finished.The bronchoscope was put through the oer (olympus endoscope reprocessor) machine and nothing was detected either.The scope was then hung clean and was used onto the next patient.During set up for the case they experienced no problems with the scope.Then, the tip of the brush that was lodged inside the bronchoscope, ended up falling inside the patient.In the physician's opinion, the patient developed an infection and required a follow-up procedure to remove the brush that had been left inside.Reportedly, the physician was not sure why he missed the broken brush and there were no attempts made to retrieved it during the initial bronchoscopy.Therefore, an additional procedure was performed to remove the device successfully using a rescue forceps.There were no patient complications during the retrieval, and it is unknown what was done to treat the patient infection, post initial bronchoscopy procedure.The patient's condition at the conclusion of the procedure was reported to be "fully recovered".
Additional Manufacturer Narrative
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 event of brush break.
Additional Manufacturer Narrative
B3: date of event: date of event was approximated to (b)(6) 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 event of brush break.Correction to block b3 (date of event).Correction to block b5 (describe event or problem).
Event or Problem Description
Note: this report pertains to the one hedgehog double-end brush used during scope cleaning and prior procedure retained in the scope.Refer to manufacturer report# 3005099803-2025-02766 for the hedgehog double-end brush (device malfunction report) and 3005099803-2025-02767 for the hedgehog double-end brush (serious injury report) it was reported to boston scientific corporation that a hedgehog double-end brush was used during a scope cleaning on an unknown date.During scope cleaning, the tip of the brush broke off and remained lodged inside the bronchoscope.The tech was cleaning and did not notice the broken brush until the reprocessing was finished.The bronchoscope was put through the oer (olympus endoscope reprocessor) machine and nothing was detected.

• 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: arlene acevedo gutierrez ; 300 boston scientific way; marlborough, MA 01752 ; 7877968283
• MDR Report Key: 22236229
• Report Number: 3005099803-2025-02766
• Device Sequence Number: 20839864
• Product Code: MNL
• UDI-Device Identifier: 00816849010083
• UDI-Public: (01)00816849010083
• Combination Product (Y/N): N
• Initial Reporter State: CT
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/11/2025

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?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/27/2025
• Supplement Date Received by Manufacturer: 06/18/2025
• Initial Report FDA Received Date: 06/17/2025
• Supplement Report FDA Received Date: 07/11/2025
• 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