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 Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/19/2022
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 december 19, 2022.During scope cleaning the tip of the brush was damaged and was left behind in the endoscope.It was not reported if the bristles were removed from the scope.There was no patient involvement with this event.
Additional Manufacturer Narrative
This is a non-sterile device with no expiration date.(b)(4).
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 tip of the brush was damaged and was left behind in the endoscope.There was no patient involvement with this event.
Additional Manufacturer Narrative
Block d4: this is a non-sterile device with no expiration date.Block e1 block h6: device code a0401 captures the reportable event of the tip of the brush break.Block h10: investigation results the returned hedgehog double-end brush was analyzed.Visual evaluation found that one brush head was detached from the catheter.The twisted wire was broken into two, a section of the wire along with some bristles remained inside the catheter, and the bristles on the brush that had broken off were crushed and mangled.The brush head on the opposite end of the catheter was attached, however it was observed that the bristles had potentially detached from the twisted wire, as a gap in the wire near the catheter was observed.Additionally, the catheter was slightly kinked in one location.The device passed dimensional inspection.No other problems were noted.The reported event was confirmed.Product analysis identified that one brush head detached from the catheter, and bristles were missing from the second brush head.It was reported that the tip of the brush was damaged and was left behind in the endoscope.It is likely that excessive force and bending or twisting of the brush caused the metal wire to separate during use.Additionally, the gap in the brush head with missing bristles suggests that the brush was twisted during use.The brush damage noted is likely due to aggressive handling of the brush during use, possibly due to an artifact inside the scope being cleaned or the need to clean a used scope aggressively.Therefore, the probable cause of the reported event was determined to be unintended use error caused or contributed to 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
• 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: 16147906
• Report Number: 3005099803-2022-08073
• Device Sequence Number: 20272068
• Product Code: MNL
• UDI-Device Identifier: 00816849010083
• UDI-Public: 00816849010083
• 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,Followup
• Report Date (Section B): 02/24/2023

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-228-50
• Device Catalogue Number: 60252
• Device Lot Number: 0000220119
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/20/2022
• Supplement Date Received by Manufacturer: 02/01/2023
• Initial Report FDA Received Date: 01/12/2023
• Supplement Report FDA Received Date: 02/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/23/2022
• 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