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

Model Number	SBD-291-50
Medical Device Problem Codes	Difficult to Remove (1528); Material Integrity Problem (2978); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/09/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation that a hedgehog double-end brush was used during a scope cleaning on (b)(6) 2022.During scope cleaning, the hedgehog long brush side became caught and could not be released, despite multiple attempts.The endoscope was shipped to olympus for repair, which is expected to take some time.The physician stated that the cause is unknown at this time, but probable flaws could result in repair costs.There was no patient involvement with this event.Investigation results revealed the brush was broken; therefore, this is now an mdr reportable event (see block h10 for investigation details).
Additional Manufacturer Narrative
(b)(6).Block h10: the returned trapezoid basket was analyzed, and a visual evaluation noted that the that the returned brush had separated; the large brush head was separated from the catheter.There was no evidence of material defect or deformation at the area where the brush head had separated.The ball tip diameter of both brush heads was determined to be within specification.Signs of damage to the working length was seen in the form of scratches.The reported event was not confirmed.Based on all available information, it is possible that factors of the procedure and interaction with the working channel of the scope caused the reported event of failure to remove to occur.Therefore, the most probable root cause is adverse event related to procedure.A labeling review was performed and, from the information available, this device was used per the instructions for use (ifu) / product label.

• Brand Name: HEDGEHOG
• Common Device Name: ACCESSORIES, CLEANING BRUSHES, FOR ENDOSCOPE
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): SUZHOU TEMEIRUL MEDICAL PRODUCTS CO; no 699 pinan road puzhuang; linhu to; suzhou, 100 21510 5; CH 215105
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 17577342
• Report Number: 3005099803-2023-04396
• Device Sequence Number: 8957398
• 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
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/18/2023

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: 0000220618
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/26/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/27/2023
• Initial Report FDA Received Date: 08/18/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/21/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown