MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION RX CYTOLOGY BRUSH; ENDOSCOPIC CYTOLOGY BRUSH

Model Number	M00545000
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/15/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Imdrf device code a0501 captures the reportable event of brush detached.
Event or Problem Description
It was reported to boston scientific corporation that a 2.1mm wireguided rx cytology brush was used during an endoscopic retrograde cholangiopancreatography procedure in the common bile duct performed on (b)(6) 2023.During preparation, the bristled part of the device was damaged.The procedure was completed with a similar rx cytology brush.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block h6: imdrf device code a0501 captures the reportable event of brush detached.Block h10: investigation results: an rx cytology brush was received for analysis, and a visual inspection of the returned device revealed the handle was kinked.No other problems were noted.The reported event of brush detached was not confirmed because the results of the analysis performed showed that the brush was in good condition.Most likely, procedural factors such as the handling of the device and the technique used by the physician during initial use, set-up, or shortly thereafter could have affected its condition and caused the handle to kink.Based on the information available and the returned device analysis, the most probable root cause for the reported complaint is no problem detected and the most probable root cause for the failure found during analysis (handle - bent/kinked) is adverse event related to procedure.
Event or Problem Description
It was reported to boston scientific corporation that a 2.1mm wireguided rx cytology brush was used during an endoscopic retrograde cholangiopancreatography procedure in the common bile duct performed on (b)(6) 2023.During preparation, the bristled part of the device was damaged.The procedure was completed with a similar rx cytology brush.There were no patient complications reported as a result of this event.

• Brand Name: RX CYTOLOGY BRUSH
• Common Device Name: ENDOSCOPIC CYTOLOGY BRUSH
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 780 brookside drive; spencer IN 47460
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 16722994
• Report Number: 3005099803-2023-01772
• Device Sequence Number: 7883396
• Product Code: FDX
• UDI-Device Identifier: 08714729268628
• UDI-Public: 08714729268628
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K930348
• 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): 06/01/2023

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 Expiration Date: 07/31/2024
• Device Model Number: M00545000
• Device Catalogue Number: 4500
• Device Lot Number: 0029863714
• 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: 03/16/2023
• Supplement Date Received by Manufacturer: 05/12/2023
• Initial Report FDA Received Date: 04/12/2023
• Supplement Report FDA Received Date: 06/01/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/01/2022
• 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 Age: 67 YR
• Patient Sex: Male
• Patient Weight: 73 KG