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

Model Number	SBB-382-50
Medical Device Problem Codes	Break (1069); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	No Patient Involvement (2645); No Known Impact Or Consequence To Patient (2692)
Date of Event	10/15/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The device has been received for analysis.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 dual-end brush was used during a scope cleaning on (b)(6), 2019.According to the complainant, the bristles broke off in the scope channel.Another brush was used to complete the cleaning of the scope.There was no patient involvement.
Event or Problem Description
It was reported to boston scientific corporation that a hedgehog dual-end brush was used during a scope cleaning on (b)(6) 2019.According to the complainant, the bristles broke off in the scope channel.Another brush was used to complete the cleaning of the scope.There was no patient involvement.Additional information received as of 07nov2019.The bristles were removed by pushing it out of the scope channel.
Additional Manufacturer Narrative
Device code 1069 captures the reportable event of brush break.One hedgehog double-end valve brush was received.Visual analysis found that the hedgehog brush was missing bristles from the channel brush and there were kinks along the length of the device.Based on the evaluation of the returned device, the damage is consistent with forceful application of the brush through a scope.A labeling review was performed and found no evidence of misuse.However, it is likely that the user did not follow instruction exerting excessive force on the brush.The directions for use (dfu) states that "endoscope channels may be damaged if brushes are forced through when channels are occluded or if resistance is met during brush passage." therefore, the most probable cause for this event is failure to follow instructions, which indicates that the problem is traced to the user not following the manufacturer's instructions.The device history record (dhr) review found the device met all manufacturing specifications.

• 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: 9278735
• Report Number: 3005099803-2019-05367
• Device Sequence Number: 2589216
• Product Code: MNL
• UDI-Device Identifier: 00816849016900
• UDI-Public: 00816849016900
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• 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): 12/02/2019

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 Expiration Date: 12/04/2023
• Device Model Number: SBB-382-50
• Device Catalogue Number: 60252
• Device Lot Number: 0000181110
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/30/2019
• Initial Date Received by Manufacturer: 10/15/2019
• Supplement Date Received by Manufacturer: 11/07/2019
• Initial Report FDA Received Date: 11/05/2019
• Supplement Report FDA Received Date: 12/02/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1