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	01/15/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The complainant was unable to provide the suspect device lot number; therefore, the device manufacture date is unknown.This is a non-sterile device with no expiration date.(b)(4).Although the suspect device has been received for analysis, 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 double-end brush was used on (b)(6) 2019.According to the complainant, during scope reprocessing, the bristles from the hedgehog brush detached in the scope.The bristles were removed manually from the scope.It was reported that another hedgehog brush was used to complete scope cleaning.There was no patient involvement with this event.
Additional Manufacturer Narrative
The complainant was unable to provide the suspect device lot number; therefore, the device manufacture date is unknown.This is a non-sterile device with no expiration date.Visual inspection of the returned device found that the brush bristles had broken off of the brush head, likely as a result of mechanical force during use.The bristles were not returned.Based on the evaluation of the returned device, the damage is consistent with forceful application of the brush through a scope, likely as a result of an occluded scope channel.A labeling review was performed and from the information available, this device was used in a manner inconsistent per the directions for use (dfu) / label.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.
Event or Problem Description
It was reported to boston scientific corporation that a hedgehog double-end brush was used on january 15, 2019.According to the complainant, during scope reprocessing, the bristles from the hedgehog brush detached in the scope.The bristles were removed manually from the scope.It was reported that another hedgehog brush was used to complete 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: 8329495
• Report Number: 3005099803-2019-00640
• Device Sequence Number: 1739685
• Product Code: MNL
• UDI-Device Identifier: 00816849010083
• UDI-Public: 00816849010083
• Combination Product (Y/N): N
• 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): 03/08/2019

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 Model Number: SBD-228-50
• Device Catalogue Number: 60252
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/24/2019
• Initial Date Received by Manufacturer: 01/15/2019
• Supplement Date Received by Manufacturer: 02/11/2019
• Initial Report FDA Received Date: 02/11/2019
• Supplement Report FDA Received Date: 03/08/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1