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	11/22/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block e1: (b)(6) university.Block h6: imdrf device code a0401 captures the reportable event of brush detachment.
Event or Problem Description
It was reported to boston scientific corporation that an rx cytology brush was used during an endoscopic retrograde cholangiopancreatography (ercp) procedure on (b)(6), 2023.During the procedure, the tip of the biliary brush was damaged and had a gap while the patient was being treated for upper abdominal discomfort.However, the tip was not detached and did not fall inside the patient.The procedure was completed using another rx cytology brush.There were no patient complications reported as a result of this event.
Event or Problem Description
It was reported to boston scientific corporation that an rx cytology brush was used during an endoscopic retrograde cholangiopancreatography (ercp) procedure on (b)(6) 2023.During the procedure, the tip of the biliary brush was damaged and had a gap while the patient was being treated for upper abdominal discomfort.However, the tip was not detached and did not fall inside the patient.The procedure was completed using another rx cytology brush.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block e1: healthcare facility name: (b)(6).Block h6: imdrf device code a0401 captures the reportable event of brush detachment.Block h6: investigation results: the returned rx cytology brush was analyzed and showed that the working length was kinked.A functional test was performed and attempted to extend the brush out of the sheath; however, it would not extend due to several kinks found in the working channel.The reported event was not confirmed.No manufacturing deviations were found in the manufacturing process that could determine the reported event of brush detached.However, the technique applied to the device and excessive force could have contributed to the working length being kinked.Based on the analysis, adverse event related to procedure was selected as the most probable root cause for this complaint.

• 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: 18333141
• Report Number: 3005099803-2023-06633
• Device Sequence Number: 8424965
• 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): 02/07/2024

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: 01/05/2025
• Device Model Number: M00545000
• Device Catalogue Number: 4500
• Device Lot Number: 0030801626
• 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: 11/23/2023
• Supplement Date Received by Manufacturer: 01/16/2024
• Initial Report FDA Received Date: 12/14/2023
• Supplement Report FDA Received Date: 02/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/06/2023
• 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: 77 KG