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

Model Number M00545000

Device Problems Detachment of Device or Device Component (2907); Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 03/15/2023

Event Type  malfunction  

Manufacturer Narrative

Imdrf device code a0501 captures the reportable event of brush detached.

Event Description

It was reported to boston scientific corporation that a 2.1mm wireguided rx cytology brush was used during an endoscopic retrograde cholangiopancreatography procedure in the common bile duct performed on (b)(6) 2023.During preparation, the bristled part of the device was damaged.The procedure was completed with a similar rx cytology brush.There were no patient complications reported as a result of this event.

Manufacturer Narrative

Block h6: imdrf device code a0501 captures the reportable event of brush detached.Block h10: investigation results: an rx cytology brush was received for analysis, and a visual inspection of the returned device revealed the handle was kinked.No other problems were noted.The reported event of brush detached was not confirmed because the results of the analysis performed showed that the brush was in good condition.Most likely, procedural factors such as the handling of the device and the technique used by the physician during initial use, set-up, or shortly thereafter could have affected its condition and caused the handle to kink.Based on the information available and the returned device analysis, the most probable root cause for the reported complaint is no problem detected and the most probable root cause for the failure found during analysis (handle - bent/kinked) is adverse event related to procedure.

Event Description

It was reported to boston scientific corporation that a 2.1mm wireguided rx cytology brush was used during an endoscopic retrograde cholangiopancreatography procedure in the common bile duct performed on (b)(6) 2023.During preparation, the bristled part of the device was damaged.The procedure was completed with a similar rx cytology brush.There were no patient complications reported as a result of this event.

• 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: 16722994
• MDR Text Key: 313112682
• Report Number: 3005099803-2023-01772
• Device Sequence Number: 1
• Product Code: FDX
• UDI-Device Identifier: 08714729268628
• UDI-Public: 08714729268628
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K930348
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/01/2023

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: 0029863714
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/16/2023
• Initial Date FDA Received: 04/12/2023
• Supplement Dates Manufacturer Received: 05/12/2023
• Supplement Dates FDA Received: 06/01/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/01/2022
• 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
• Patient Age: 67 YR
• Patient Sex: Male
• Patient Weight: 73 KG