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 Patient Involvement (2645)
Date of Event	08/24/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Expiration date: 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 brush was used during scope cleaning on (b)(6) 2020.According to the complainant, during scope cleaning, the brush was detached and a bristle was left inside the scope.A pair of forceps was used to remove the bristle from the scope.The scope cleaning was completed with the original device.There was no patient involvement with this event.
Additional Manufacturer Narrative
Block d4: expiration date this is a non-sterile device with no expiration date.Block h6: device code 1069 captures the reportable event of brush break.Block h10: investigation results one hedgehog brush was received for analysis with one of the brush heads detached from the base.The brush head was intact.Based on all available information and the condition of the returned device, it is possible that forceful manipulation such as twisting of the device inside the scope could have resulted in the brush head detaching.The investigation concluded the most probable cause is unintended use error.A review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.A labeling review was performed and, from the information available, this device was used per the directions for use (dfu) / product label.
Event or Problem Description
It was reported to boston scientific corporation that a hedgehog brush was used during scope cleaning on (b)(6) 2020.According to the complainant, during scope cleaning, the brush was detached and a bristle was left inside the scope.A pair of forceps was used to remove the bristle from the scope.The scope cleaning was completed with the original device.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: 10546807
• Report Number: 3005099803-2020-03994
• Device Sequence Number: 3135007
• Product Code: MNL
• UDI-Device Identifier: 00816849016900
• UDI-Public: 00816849016900
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• 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): 12/18/2020

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: SBB-382-50
• Device Catalogue Number: 60252
• Device Lot Number: 0000190326
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/21/2020
• Initial Date Received by Manufacturer: 08/24/2020
• Supplement Date Received by Manufacturer: 11/23/2020
• Initial Report FDA Received Date: 09/17/2020
• Supplement Report FDA Received Date: 12/18/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1