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	09/16/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4), captures the reportable event of brush detached.
Event or Problem Description
It was reported to boston scientific corporation that an rx cytology brush was used for epigastric discomfort in the stomach during an endoscopic retrograde cholangiopancreatography (ercp) procedure and biliary brush examination performed on (b)(6) 2022.During preparation, it was found that there was a gap on the tip of the brush.The procedure was completed with another of the same device.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.
Additional Manufacturer Narrative
Block h6: problem 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 returned disassembled as the blue knob was unscrewed.In addition, the working length was bent, and the brush was used based on residue noted.Microscope inspection of the returned device revealed that the tip of the brush was in good condition.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 as handling of the device, the technique used by the physician during initial use, set-up, or shortly thereafter could have affected its condition and caused the working length kink and handle disassembly.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 failures found during analysis (working length - bent/kinked) is adverse event related to procedure.
Event or Problem Description
It was reported to boston scientific corporation that an rx cytology brush was used for epigastric discomfort in the stomach during an endoscopic retrograde cholangiopancreatography (ercp) procedure and biliary brush examination performed on (b)(6) 2022.When the physician examined the medical devices before procedure, the tip was damaged and notched.The procedure was completed with another of the same device.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.

• 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: 15590070
• Report Number: 3005099803-2022-05837
• Device Sequence Number: 20627871
• 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): 12/02/2022

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: 06/02/2023
• Device Model Number: M00545000
• Device Catalogue Number: 4500
• Device Lot Number: 0027421629
• 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: 09/16/2022
• Supplement Date Received by Manufacturer: 11/08/2022
• Initial Report FDA Received Date: 10/12/2022
• Supplement Report FDA Received Date: 12/02/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/02/2021
• 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: 58 YR
• Patient Sex: Male
• Patient Weight: 68 KG