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

Model Number	SBD-291-50
Medical Device Problem Codes	Break (1069); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	10/01/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The complainant was unable to provide the suspect device lot number; therefore, the device manufacture date.This is a non-sterile device with no expiration date.(b)(6).(b)(4).Although the suspect device has been received, the evaluation has not been completed.Therefore, the cause of the reported malfunction has not been determined.Upon 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 clearning, the white ball tip of the brush detached and clogged the scope channel.Scope cleaning was completed using anther hedgehog sweeper brush.Reportedly, the scope was sent for repair and the tip of the brush was removed.There was no patient involvement with this event.
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 clearing, the white ball tip of the brush detached and clogged the scope channel.Scope cleaning was completed using anther hedgehog sweeper brush.Reportedly, the scope was sent for repair and the tip of the brush was removed.There was no patient involvement with this event.
Additional Manufacturer Narrative
Block d4, h4: the complainant was unable to provide the suspect device lot number; therefore, the device manufacture date.This is a non-sterile device with no expiration date.Block e1: initial reporter address (b)(6).Block h6: device code 1069 captures the reportable event of brush bristle detached.Block h10: one hedgehog brush was received for analysis.A visual analysis of the returned device found that the ball tip of the larger brush head was detached and not returned.No other issues noted.Based on the available information, it is likely that the ball tip became stuck in the scope.As the ball tip was not returned for analysis, it is unconfirmed whether the ball tip was out of specification.The complaint is assigned a probable cause of manufacturing deficiency.An investigation is in place to address ball tip size out of the upper specification limit.A review of the manufacturing documentation for this device was unable to be performed as the lot number is unknown.However, a ship history review was performed to identify the most probable lots and a manufacturing review of the most probable lots did not identify any anomalies or deviations that could have contributed to the 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: 10851671
• Report Number: 3005099803-2020-05506
• Device Sequence Number: 19437857
• 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): 01/13/2021

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-291-50
• Device Catalogue Number: 60252
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/16/2020
• Initial Date Received by Manufacturer: 10/23/2020
• Supplement Date Received by Manufacturer: 12/23/2020
• Initial Report FDA Received Date: 11/17/2020
• Supplement Report FDA Received Date: 01/13/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1