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

Model Number	SBB-382
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/07/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block d4: this is a non-sterile device with no expiration date.Block h6: imdrf device code a0401 captures the reportable event of brush break.
Event or Problem Description
It was reported to boston scientific corporation that a hedgehog double bundle was used during a scope cleaning performed on (b)(6) 2023.During the cleaning of duodenoscope, the brush detached from the clear plastic handle.The detached brush was retrieved by hand.The scope cleaning was completed with another of the same device.There was no patient involvement in the event.
Event or Problem Description
It was reported to boston scientific corporation that a hedgehog double bundle was used during a scope cleaning performed on (b)(6) 2023.During the cleaning of duodenoscope, the brush detached from the handle on valve brush.The detached brush was retrieved by hand.The scope cleaning was completed with another of the same device.There was no patient involvement in the event.
Additional Manufacturer Narrative
Block d4: this is a non-sterile device with no expiration date.Block h6: imdrf device code a0401 captures the reportable event of brush break.Block h10: investigation results: the returned hedgehog dual-end brush was analyzed.Visual evaluation found that the large brush head was separated from the catheter and bent.No other problems were noted.The reported event was confirmed.It is possible that excessive or twisting force was applied to the brush during use, resulting in the separation.Based on all available information and analysis of the returned device, the most probable is unintended use error caused or contributed to event.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): CHANGZHOU TEMEIRUI MEDICAL; building 34 no 249; middle liangchan; changzhou, 100 21320 0; CH 213200
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 17851980
• Report Number: 3005099803-2023-05154
• Device Sequence Number: 17850143
• Product Code: MNL
• UDI-Device Identifier: 00840253114020
• UDI-Public: 00840253114020
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• 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): 12/12/2023

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: SBB-382
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/07/2023
• Supplement Date Received by Manufacturer: 11/15/2023
• Initial Report FDA Received Date: 10/02/2023
• Supplement Report FDA Received Date: 12/12/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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