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); Use of Device Problem (1670); 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	11/13/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block d4: 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.Visual evaluation found that the double-sided brush observed kinks along the catheter.One brush head was bent, and it was noted that some brush bristles were missing from the end of both brushes.No other problems were noted.The reported complaint of brush failure to remove and use of device issues were confirmed.The presence of bent brush heads and missing bristles is consistent with excessive force applied during use of the device, potentially due to excess torque applied, or forcing the brush when an obstruction was encountered.Additionally, the customer reported that the hedgehog brush was reused.The direction for use (dfu) warns against reusing the device and applying excessive force and torquing.Based on all available information and analysis of the returned device, the most probable cause is use of device issue -user error, indicating that the interaction between the user and device caused or contributed to the event.
Event or Problem Description
It was reported to boston scientific corporation that a hedgehog dual end brush was used for scope cleaning following an upper gastrointestinal tract procedure on (b)(6) 2024.The brush was inserted through the forceps channel of the endoscope and pulled approximately 90cm from the tip of the scope.At this point, the brush became stuck and could not be moved, either by pulling or pushing.The scope was sent for repair to remove the brush, and the scope cleaning could not be completed.It was reported this brush had been reused prior to this event.There were no patient complications reported as a result after this event.The hedgehog directions for use (dfu), specify 'do not reuse' and 'mechanical integrity may be compromised by reuse'.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.Please see block h11 for full investigation details.

• 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: 22030867
• Report Number: 3005099803-2025-02202
• Device Sequence Number: 8476049
• Product Code: MNL
• UDI-Device Identifier: 00816849010083
• UDI-Public: 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): 05/15/2025

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
• Device Lot Number: 0000231220
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/17/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/22/2025
• Initial Report FDA Received Date: 05/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/25/2023
• 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