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

Model Number	M00545000
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/20/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.
Event or Problem Description
It was reported to boston scientific corporation that an rx cytology brush was prepared for use in the bile duct during an endoscopic retrograde cholangiopancreatography (ercp) endoscopic lithotripsy procedure performed on (b)(6) 2021.During preparation and outside the patient, the brush did not extend and it was reported that the patient was sedated when the event occurred.It was also reported that the patient could not accept the prolonged procedure which resulted in cancellation of the procedure.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.
Additional Manufacturer Narrative
Block h6: impact code f1001 is being used to capture the reportable issue of aborted/cancelled procedure.Block h10: investigation results one rx cytology brush was received for analysis.Visual analysis of the returned device revealed that the working length was kinked and the handle was kinked.Functional evaluation was performed and it was noted that there was resistance when the handle was actuated.The reported event was confirmed.It's most likely that user manipulation during the unpackaging of the device and/or some technique performed during the preparation of the device resulted in kinking the working length.Once the working length was kinked, the user may have experienced difficulties with extending the brush which may have led to them applying extra force kinking the handle.Based on the information available and the analysis performed, the most probable root cause for this problem is adverse event related to procedure.A review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.
Event or Problem Description
It was reported to boston scientific corporation that an rx cytology brush was prepared for use in the bile duct during an endoscopic retrograde cholangiopancreatography (ercp) endoscopic lithotripsy procedure performed on (b)(6) 2021.During preparation and outside the patient, the brush did not extend and it was reported that the patient was sedated when the event occurred.It was also reported that the patient could not accept the prolonged procedure which resulted in cancellation of the procedure.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.

• 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: 13281742
• Report Number: 3005099803-2021-08233
• Device Sequence Number: 4964325
• 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): 02/22/2022

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: 09/01/2022
• Device Model Number: M00545000
• Device Catalogue Number: 4500
• Device Lot Number: 0025952464
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/19/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/20/2021
• Supplement Date Received by Manufacturer: 01/26/2022
• Initial Report FDA Received Date: 01/18/2022
• Supplement Report FDA Received Date: 02/22/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/01/2020
• 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: Female
• Patient Weight: 68 KG