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	06/19/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(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 nasal endoscope cleaning, the brush got stuck inside the endoscope channel.When the brush was removed, it was found that the tip of the brush was missing.Another hedgehog sweeper brush was used to complete the cleaning.Reportedly, leak test was performed and the scope is used continuously.There was no patient involvement.
Additional Manufacturer Narrative
Block h6: device code 1069 captures the reportable event of brush tip detached.Conclusion code 4316 is being used in lieu of an adequate conclusion code for "device not returned".Block h10: 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 nasal endoscope cleaning, the brush got stuck inside the endoscope channel.When the brush was removed, it was found that the tip of the brush was missing.Another hedgehog sweeper brush was used to complete the cleaning.Reportedly, leak test was performed and the scope is used continuously.There was no patient involvement.***additional information received as of (b)(6),2020*** there was severe resistance while the brush is being advanced in the working channel and distal portion of the brush got stuck in the scope.

• 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: 10272174
• Report Number: 3005099803-2020-02761
• Device Sequence Number: 16346643
• 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): 08/11/2020

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: 0000191017
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/19/2020
• Supplement Date Received by Manufacturer: 07/17/2020
• Initial Report FDA Received Date: 07/14/2020
• Supplement Report FDA Received Date: 08/11/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1