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

Model Number	M00545000
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/27/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H6: imdrf device code a0501 captures the reportable event of brush detachment.
Event or Problem Description
It was reported to boston scientific corporation that an rx cytology brush was to be used in the common bile duct during an endoscopic retrograde cholangiopancreatography procedure performed on (b)(6) 2024.Prior to the procedure, it was reported that the bristles of the brush were broken/missing.The procedure was completed using another 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: 18957076
• Report Number: 3005099803-2024-01079
• Device Sequence Number: 21173370
• Product Code: FDX
• UDI-Device Identifier: 08714729268628
• UDI-Public: 08714729268628
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/22/2024

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: 04/18/2024
• Device Model Number: M00545000
• Device Catalogue Number: 4500
• Device Lot Number: 0029249424
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/27/2024
• Initial Report FDA Received Date: 03/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/19/2022
• 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 Sex: Unknown