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

Model Number	SBB-382-50
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/23/2021
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 double bundle was used during scope cleaning on (b)(6) 2021.After the scope went through the reprocessing machine, a bristle was found on the tip of the scope.The bristle was wiped off with gauze.There was no patient involvement with this event.
Additional Manufacturer Narrative
Block d4: this is a non-sterile device with no expiration date.Block h6: device code a0401captures the reportable event of bristle detached.Block h10: visual analysis of the returned device, there is no evidence identified that bristles were missing from the returned brush heads.Based on all available information and the condition of the returned device, it is likely that the reported event could have been affected by handling technique and device manipulation during the procedure.Therefore, based on all gathered information, the device break event is assigned a probable cause of unintended use error caused or contributed to event which indicates the interaction between the user and device, or sample, caused or contributed to the error.A review of the device history record (dhr) confirmed that the device met all material, assembly, and product specifications at the time of release to distribution.A labeling review was performed and, from the information available, this device was used per the instructions for use (ifu) / product label.
Event or Problem Description
It was reported to boston scientific corporation that a hedgehog double-end brush was used during scope cleaning on (b)(6), 2021.According to the complainant, after the scope went through the reprocessing machine, a bristle was found on the tip of the scope.The bristle was wiped off with gauze.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: 11694441
• Report Number: 3005099803-2021-01841
• Device Sequence Number: 3495191
• Product Code: MNL
• UDI-Device Identifier: 00816849016900
• UDI-Public: 00816849016900
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 07/21/2021

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: SBB-382-50
• Device Catalogue Number: 60252
• Device Lot Number: 0000200318
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/21/2021
• Initial Date Received by Manufacturer: 03/26/2021
• Supplement Date Received by Manufacturer: 06/29/2021
• Initial Report FDA Received Date: 04/20/2021
• Supplement Report FDA Received Date: 07/21/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1