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

Model Number	SBD-289-50
Medical Device Problem Codes	Break (1069); Defective Device (2588)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/17/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation that a hedgehog double-end brush was used during a scope cleaning performed on (b)(6) 2022.During scope cleaning, the little brush fell apart when cleaning the scope.The procedure was completed with another hedgehog double-end brush.There was no patient involvement with this event.
Additional Manufacturer Narrative
The complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.(b)(4).
Additional Manufacturer Narrative
Block d4 and h4: the complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.Block h6: device code a0401 captures 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 a scope cleaning performed on october 17, 2022.During scope cleaning, the little brush fell apart when cleaning the scope.The procedure was completed with another hedgehog double-end brush.There was no patient involvement with this event.
Additional Manufacturer Narrative
Block d4 and h4: the complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.Block h6: device code a0401 captures the reportable event of brush break.Block h10 investigation results: one hedgehog double-end brush was received for analysis.A visual analysis was performed, and it was observed that the large brush head was slightly bent.The small brush head was bent over onto itself.No missing bristles could be detected.A media review of the photo provided by the customer was performed.The photos demonstrated bent brush heads on both ends of the device.It could not be determined from the photo whether bristles were missing.The ball tip on the small brush head was dimensionally inspected and was within specification.No other problems were noted.The reported event of brush bent was confirmed.Visual analysis of the returned device and media analysis of the photo provided found both brush heads were bent.The reported event of brush break was not confirmed as no missing bristles could be detected during visual and media analysis.The bent brush heads are likely due to aggressive handling of the brush during use, or an artifact inside the scopes being cleaned that is resulting in damage or requiring excessive force during use.Based on all available information, the most probable root cause is adverse event related to procedure.Block h11: block b5 has been corrected.Block d4: unique identifier (udi) has been corrected.Block d5 has been corrected.Block h6 device code has been corrected.
Event or Problem Description
It was reported to boston scientific corporation that a hedgehog double-end brush was used during a scope cleaning performed on (b)(6) 2022.During scope cleaning, the little brush fell apart when cleaning the scope.The procedure was completed with another hedgehog double-end brush.There was no patient involvement with this event.A photo provided showed the large and small brush head bent and appeared to show bristles detached.

• 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): SUZHOU TEMEIRUL MEDICAL PRODUCTS CO; no 699 pinan road puzhuang; linhu to; suzhou, 100 21510 5; CH 215105
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 15776974
• Report Number: 3005099803-2022-06416
• Device Sequence Number: 20502028
• Product Code: MNL
• UDI-Device Identifier: 00816849010083
• UDI-Public: 00816849010083
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/09/2023

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?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/17/2022
• Supplement Date Received by Manufacturer: 11/17/2022; 12/14/2022
• Initial Report FDA Received Date: 11/10/2022
• Supplement Report FDA Received Date: 12/13/2022; 01/09/2023
• 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