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

Model Number	SBD-228-50
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	09/28/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This is a non-sterile device with no expiration date.(b)(4).The device has been received for analysis; however, the analysis has not yet been completed.Upon completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.
Event or Problem Description
It was reported to boston scientific corporation that a hedgehog brush was used during scope cleaning on an unknown date.According to the complainant, during scope cleaning, all the bristles on one end of the brushes detached.No scratch or damage was noted on the endoscope.Reportedly, another of the same hedgehog brush was used to sweep the bristles found in the scope and completed the scope cleaning.There was no patient involvement with this event.
Additional Manufacturer Narrative
Block d4: this is a non-sterile device with no expiration date.Block h6: device code 1069 captures the reportable event of brush bristle detached.Block h10: investigation results one hedgehog brush was received for analysis with missing bristles from the brush head.Based on the evaluation of the returned device, the damage is consistent with forceful application of the brush through a scope.The valve brush had bristles missing from center section.The damage is consistent with forceful application of the brush, through the valve port.The ifu states, "endoscope channels may be damaged if brushes are forced through when channels are occluded or if resistance is met during brush passage." additionally, the ifu instructs the user to 'avoid twisting or torqueing the brush handle'.Therefore, the most probable cause of the reported event is failure to follow instructions, which indicates that the problem is traced to the user not following the manufacturer's instructions.A review of the device history record (dhr) confirmed that the device met all material, assembly, and product specifications at the time of release to distribution.
Event or Problem Description
It was reported to boston scientific corporation that a hedgehog brush was used during scope cleaning on an unknown date.According to the complainant, during scope cleaning, all the bristles on one end of the brushes detached.No scratch or damage was noted on the endoscope.Reportedly, another of the same hedgehog brush was used to sweep the bristles found in the scope and completed the scope cleaning.There was no patient involvement with this event.

• Brand Name: HEDGEHOG
• Common Device Name: ACCESSORIES, CLEANING BRUSHES, FOR ENDOSCOPE
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 10720035
• Report Number: 3005099803-2020-04818
• Device Sequence Number: 3060927
• 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
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/11/2021

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: 0000190116
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/19/2020
• Initial Date Received by Manufacturer: 09/29/2020
• Supplement Date Received by Manufacturer: 12/16/2020
• Initial Report FDA Received Date: 10/22/2020
• Supplement Report FDA Received Date: 01/11/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1