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

Model Number	M00545000
Medical Device Problem Codes	Break (1069); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/15/2024
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 common bile duct during a biopsy procedure performed on (b)(6) 2024.During the procedure, the wire in the sheath was damaged/defective.It was also reported that the handle was difficult to operate, and an unusual noise was observed.The procedure was completed with another of the same device.There were no patient complications as a result of this event.Boston scientific has been unable to obtain additional information regarding the malfunction of the device, despite good faith efforts.
Additional Manufacturer Narrative
Block h6: imdrf device code a0402 captures the reportable event of wire break.
Additional Manufacturer Narrative
Block h6: imdrf device code a0402 captures the reportable event of wire break.Block h10: investigation results.The returned rx cytology brush was analyzed, and it was found that the wire was damaged (buckled) inside the injection port, and it was not broken.In addition, the handle was not broken.The reported events of handle and wire break were not confirmed.The investigation finding of wire damaged (buckled) could have been generated due to excessive force applied possibly causing the working length to kink when the brush was extended or retracted.Based on all available information, the most probable root cause of the reported event is no problem detected.
Event or Problem Description
It was reported to boston scientific corporation that an rx cytology brush was used in the common bile duct during a biopsy procedure performed on (b)(6) 2024.During the procedure, the wire in the sheath was damaged/defective.It was also reported that the handle was difficult to operate, and an unusual noise was observed.The procedure was completed with another of the same device.There were no patient complications as a result of this event.Boston scientific has been unable to obtain additional information regarding the malfunction of the device, despite good faith efforts.

• 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: 18883261
• Report Number: 3005099803-2024-00877
• Device Sequence Number: 12647288
• Product Code: FDX
• UDI-Device Identifier: 08714729268628
• UDI-Public: 08714729268628
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 04/30/2024

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: 09/11/2025
• Device Model Number: M00545000
• Device Catalogue Number: 4500
• Device Lot Number: 0032411119
• 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: 02/15/2024
• Supplement Date Received by Manufacturer: 04/08/2024
• Initial Report FDA Received Date: 03/12/2024
• Supplement Report FDA Received Date: 04/30/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/12/2023
• 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 Sex: Unknown