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

Model Number	SBD-291-50
Medical Device Problem Codes	Break (1069); Use of Device Problem (1670); Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/18/2025
Type of Reportable Event	Malfunction
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.
Event or Problem Description
It was reported to boston scientific corporation that a hedgehog sweeper brush was used during a scope cleaning on (b)(6) 2025.During the procedure, the hedgehog sweeper was advanced; however, resistance was felt at the junction around twenty centimeters from the forceps port.Despite the problem, the device was pushed forward and the tip broke off.It is unknown how the detached brush was retrieved, and the scope cleaning was completed using another of the same device.There was no patient involvement in this event.The instructions for use (ifu), endoscope channels may be damaged if brushes are forced through when channels are occluded or if resistance is met during brush passage.If sharp bends in plastic sheath or wire cable are observed during insertion, dispose of brush to avoid damaging the endoscope.
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.Block h11: correction to block e1 (initial reporter address 2 and initial reporter city).The returned hedgehog sweeper brush was analyzed.During product analysis, visual inspection observed one end of the brush detached from the catheter.The detached brush was not returned for analysis.No other visual damages were observed.The device was sent to the vendor for further analysis.With all the available information boston scientific concludes it likely that the interaction between the user and device, caused or contributed to the event.The reported event was confirmed.The costumer reported forcing the brush when an obstruction was encountered.The ifu (instructions for use) warns against excessive force and torquing.Therefore, the probable cause of the reported complaint was determined to be unintended use error caused or contributed to event.Review of labeling determined that the complaint situation was listed in the manual.A labeling review confirmed that instructions and warnings are present for the reported event.
Event or Problem Description
It was reported to boston scientific corporation that a hedgehog sweeper brush was used during a scope cleaning on (b)(6) 2025.During the procedure, the hedgehog sweeper was advanced; however, resistance was felt at the junction around twenty centimeters from the forceps port.Despite the problem, the device was pushed forward and the tip broke off.It is unknown how the detached brush was retrieved, and the scope cleaning was completed using another of the same device.There was no patient involvement in this event.The instructions for use (ifu), endoscope channels may be damaged if brushes are forced through when channels are occluded or if resistance is met during brush passage.If sharp bends in plastic sheath or wire cable are observed during insertion, dispose of brush to avoid damaging the endoscope.

• 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 WI 21320 0; CH 213200
• Manufacturer Contact: arlene acevedo gutierrez ; 300 boston scientific way; marlborough, MA 01752 ; 7877968283
• MDR Report Key: 21563589
• Report Number: 3005099803-2025-00885
• Device Sequence Number: 21233014
• Product Code: MNL
• UDI-Device Identifier: 00816849016443
• UDI-Public: (01)00816849016443
• 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,Followup
• Report Date (Section B): 06/20/2025

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: SBD-291-50
• 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: 02/18/2025
• Supplement Date Received by Manufacturer: 05/30/2025
• Initial Report FDA Received Date: 03/10/2025
• Supplement Report FDA Received Date: 06/20/2025
• 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