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

Model Number	SBD-291-50
Medical Device Problem Codes	Break (1069); Difficult to Advance (2920)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	05/19/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This is a non-sterile device with no expiration date.(b)(4).The device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental mdr will be filed.
Event or Problem Description
It was reported to boston scientific corporation that a hedgehog sweeper brush was used during scope cleaning on (b)(6) 2020.According to the complainant, during scope cleaning, resistance is met during device usage.Upon inspection, the wire at the tip of the brush was noted to be protruding.Scope cleaning was completed using another hedgehog sweeper brush.There was no patient involvement with this event.Attempts to obtain additional information regarding the circumstances surrounding this event have been unsuccessful to date.Should additional relevant details become available, a supplemental report will be submitted.
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: visual analysis of the returned device found that the tip was bare and the coating of the wire had broken and was slightly unraveled on the large plush brush head.No other issues were noted.The condition of the returned device confirms that there was a protrusion on the brush head.The directions for use (dfu) contains warnings for use of the product that would result in excessive force or potential damage to the device, and also instructs the user to inspect the device for missing or loose bristles prior to use.Based on the available information and the objective evidence, the most probalbe cause of the observed damage of the coating on the brush head unraveled was after it was broken inside the scope.However, additional information stated that the reported defect was noticed out of box.Therefore, the cause code assigned to this event is cause not established.A review of the device history record (dhr) was performed and confirmed that this device met all material, assembly and performance specifications.
Event or Problem Description
It was reported to boston scientific corporation that a hedgehog sweeper brush was used during scope cleaning on (b)(6) 2020.According to the complainant, during scope cleaning, resistance is met during device usage.Upon inspection, the wire at the tip of the brush was noted to be protruding.Scope cleaning was completed using another hedgehog sweeper brush there was no patient involvement with this event.Attempts to obtain additional information regarding the circumstances surrounding this event have been unsuccessful to date.Should additional relevant details become available, a supplemental report will be submitted.***addition information received as of september 07, 2020*** the complainant reported that the issue was noticed during unpacking of the device.

• 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: 10143880
• Report Number: 3005099803-2020-02197
• Device Sequence Number: 16907499
• Product Code: MNL
• UDI-Device Identifier: 00816849016443
• UDI-Public: 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
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/14/2020

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
• Device Lot Number: 0000190320
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/06/2020
• Initial Date Received by Manufacturer: 05/19/2020
• Supplement Date Received by Manufacturer: 08/18/2020
• Initial Report FDA Received Date: 06/11/2020
• Supplement Report FDA Received Date: 09/14/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1