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

Model Number M00545000

Device Problems Break (1069); Mechanical Problem (1384); Detachment of Device or Device Component (2907)

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

Event Date 02/07/2023

Event Type  malfunction  

Event Description

It was reported to boston scientific corporation that an rx cytology brush was used during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2023.During the procedure, the brush extended and retracted during testing; however, when the technician tried to extend the brush again, it was stuck inside the working length and did not extend.It was also noted that the working length detached, and the wire within the catheter broke.The procedure was completed with a similar rx cytology brush.There were no patient complications reported as a result of this event.

Manufacturer Narrative

Imdrf device code a0401 capture the reportable event of wire break.

• Brand Name: RX CYTOLOGY BRUSH
• Type of Device: 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: 16483640
• MDR Text Key: 310680761
• Report Number: 3005099803-2023-01018
• Device Sequence Number: 1
• Product Code: FDX
• UDI-Device Identifier: 08714729268628
• UDI-Public: 08714729268628
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K930348
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/05/2023

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
• Device Operator: Health Professional
• Device Model Number: M00545000
• Device Catalogue Number: 4500
• Device Lot Number: 0029600311
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/07/2023
• Initial Date FDA Received: 03/06/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/16/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1