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); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/01/2025
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 brush was used during a scope cleaning performed on (b)(6), 2025.The hedgehog brush was used multiple times at the hospital's discretion.An event occurred in which the molded brush part was separated and became stuck inside the scope.The scope was sent for repair to remove the brush fragment.There was no patient involvement in the event.The hedgehog directions for use (dfu), specify 'do not reuse' and 'mechanical integrity may be compromised by reuse'.
Additional Manufacturer Narrative
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: the hedgehog sweeper brush was received for analysis.Brush sweeper end is detached.The metal part is still attached.The reported event was confirmed.A labeling review confirmed that the ifu (instructions for use) includes specific warnings/instructions related to "brush break", stating that "for single use only.Do not reuse or reprocess.Reuse, reprocessing or sterilizing may compromise the structural and mechanical integrity of the device and/or lead to device failure.Reuse or reprocessing may also create a risk of cross contamination between patients or may lead to improper scope and/or accessory cleaning." there is an indication that the device was not used in accordance with the ifu.The ifu has no issues with translation, wording, or graphics and therefore revision is not required.It was confirmed the device was used during multiple cleanings.As per manufacturer instructions, the device is a single use and reprocessing may compromise the structural and mechanical integrity of the device.Since the problem was traced to the user not following the manufacturer's instructions, failure to follow instructions is assigned as the conclusion code for this event.A review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.
Event or Problem Description
It was reported to boston scientific corporation that a hedgehog brush was used during a scope cleaning performed on (b)(6) 2025.The hedgehog brush was used multiple times at the hospital's discretion.An event occurred in which the molded brush part was separated and became stuck inside the scope.The scope was sent for repair to remove the brush fragment.There was no patient involvement in the event.The hedgehog directions for use (dfu), specify 'do not reuse' and 'mechanical integrity may be compromised by reuse'.

• 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: 21920654
• Report Number: 3005099803-2025-01744
• Device Sequence Number: 9086931
• 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): 07/31/2025

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: 04/01/2025
• Supplement Date Received by Manufacturer: 07/03/2025
• Initial Report FDA Received Date: 04/28/2025
• Supplement Report FDA Received Date: 07/31/2025
• 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