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

Model Number M00545000

Device Problem Break (1069)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/02/2023

Event Type  malfunction  

Event Description

During ercp procedure, two of the boston scientific biliary rx cytology brushes broke near the handle.Both brushes were ref#(b)(4), lot#30413936.Third cytology brush used worked as anticipated.

• Brand Name: BILIARY RX CYTOLOGY BRUSHES
• Type of Device: ENDOSCOPIC CYTOLOGY BRUSH
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION
• MDR Report Key: 16352948
• MDR Text Key: 309402273
• Report Number: MW5114844
• Device Sequence Number: 2
• Product Code: FDX
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 02/07/2023
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: M00545000
• Device Lot Number: 30413936
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/09/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 77 YR
• Patient Sex: Female
• Patient Weight: 65 KG
• Patient Ethnicity: Hispanic