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

Model Number	M00545000
Medical Device Problem Codes	Mechanical Problem (1384); 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	02/20/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block e1: healthcare facility: (b)(6) university.Block h6: imdfr device code a0501 captures the reportable investigation finding of brush detached.Block h10: investigation results the returned rx cytology brush was analyzed, and it showed that the brush was detached and did not return for investigation.In addition, the handle was moved however no movement of the wire was noted.This is possibly due to the wire being detached from the handle, which was confirmed through x-ray.The reported event was confirmed.Additionally, the wire was detached from the handle and the brush was detached.Most likely, the reported event and additional investigation findings could have been due to excessive force applied when extending/retracting the brush that got the wire kinked, and later detached.The brush did not return for investigation and the reason for the brush detachment remains unknown.Based on all available information, adverse event related to procedure was selected as the most probable root cause.
Event or Problem Description
It was reported to boston scientific corporation that an rx cytology brush was used in the pancreas during an endoscopic retrograde cholangiopancreatography (ercp) procedure on (b)(6) 2024.During the procedure, the brush could not extend out of the sheath.The procedure was completed using another rx cytology brush.There were no patient complications reported as a result of this event.This event has been deemed reportable based on the investigation finding of the brush detached.Please see block h10 for full investigation details.
Additional Manufacturer Narrative
Block e1: healthcare facility: (b)(6).Block h6: imdfr device code a0501 captures the reportable investigation finding of brush detached.Block h11: investigation results: the returned rx cytology brush was analyzed, and it showed that the brush was detached and did not return for investigation.In addition, the handle was moved however no movement of the wire was noted.This is possibly due to the wire being detached from the handle, which was confirmed through x-ray.The reported event was confirmed.Additionally, the wire was detached from the handle and the brush was detached.Most likely, the reported event and additional investigation findings could have been due to excessive force applied when extending/retracting the brush that got the wire kinked, and later detached.The brush did not return for investigation and the reason for the brush detachment remains unknown.Based on all available information, adverse event related to procedure was selected as the most probable root cause.Block h11: block a1 has been corrected from (b)(6).Block a2, patient age, has been corrected from 70 to 47.Block b5 has been updated.Block g2 has been updated.
Event or Problem Description
It was reported to boston scientific corporation that an rx cytology brush was used in the pancreas during an endoscopic retrograde cholangiopancreatography (ercp) procedure on (b)(6) 2024, for the treatment of tumor of pancreas.During the procedure, the brush could not extend out of the sheath.The procedure was completed using another rx cytology brush.There were no patient complications reported as a result of this event.The patient's condition was stable following the procedure.This event has been deemed reportable based on the investigation finding of the brush detached.Please see block h10 for full investigation details.

• 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: 19220788
• Report Number: 3005099803-2024-01928
• Device Sequence Number: 20881635
• 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,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/13/2024

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: 08/09/2024
• Device Model Number: M00545000
• Device Catalogue Number: 4500
• Device Lot Number: 0029925479
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/14/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/08/2024
• Supplement Date Received by Manufacturer: 05/23/2024
• Initial Report FDA Received Date: 05/01/2024
• Supplement Report FDA Received Date: 06/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/10/2022
• 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: 47 YR
• Patient Sex: Male
• Patient Weight: 87 KG