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

Model Number	M00545000
Medical Device Problem Codes	Break (1069); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/12/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation that an rx cytology brush was used in the stomach during an endoscopic retrograde cholangiopancreatography and biliary brush examination procedure performed on (b)(6) 2023.During the procedure, the blue cap at the end of the cytology brush delivery device could not return to its original position after it was pushed out, and the tip of the biliary brush was damaged and had a gap.The procedure was completed with another rx cytology brush.There were no patient complications reported as a result of this event.No further information has been obtained despite good faith efforts.
Additional Manufacturer Narrative
Block e1 (initial reporter facility name): (b)(6) medical university.Block h6: imdrf a0501 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 in the stomach during an endoscopic retrograde cholangiopancreatography and biliary brush examination procedure performed on (b)(6) 2023.During the procedure, the blue cap at the end of the cytology brush delivery device could not return to its original position after it was pushed out, and the tip of the biliary brush was damaged and had a gap.The procedure was completed with another rx cytology brush.There were no patient complications reported as a result of this event.No further information has been obtained despite good faith efforts.
Additional Manufacturer Narrative
Block e1 (initial reporter facility name): (b)(6).Block h6: imdrf a0501 captures the reportable event of brush detached.Block h10 investigation results: one cytology brush was received for analysis.Visual and microscope analysis of the returned device found the pull wire was kinked adjacent to the handle.No other device problems were noted.The reported event of "brush detached" could not be confirmed since the brush was not detached.The product record review confirmed that this was not a new failure type and the risk was anticipated.There was no evidence of a manufacturing problem, design or user problem which could have caused the complaint.Device analysis found the pull wire was kinked outside the handle during visual and microscope test.It is most likely that during manipulation of the device an excess of force was applied to the device such as the interaction with the scope or additional tools/medical devices, causing the device to separate in two pieces.Therefore, based on analysis of the returned device and all available information, the most probable root cause for the reported event is adverse event related to procedure.

• 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: 17860576
• Report Number: 3005099803-2023-05234
• Device Sequence Number: 12185628
• 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): 12/07/2023

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: 11/08/2024
• Device Model Number: M00545000
• Device Catalogue Number: 4500
• Device Lot Number: 0030510673
• 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: 09/14/2023
• Supplement Date Received by Manufacturer: 11/13/2023
• Initial Report FDA Received Date: 10/03/2023
• Supplement Report FDA Received Date: 12/07/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/09/2022
• 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: 55 YR
• Patient Sex: Male
• Patient Weight: 67 KG