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

Model Number M00545000

Device Problems Break (1069); Detachment of Device or Device Component (2907); Material Deformation (2976)

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

Event Date 11/20/2023

Event Type  malfunction  

Manufacturer Narrative

Block h6: imdrf device code a0501 captures the reportable investigation result of brush detachment.Block h10: investigation results.The returned rx cytology brush was analyzed, and a visual evaluation noted that the device returned without the brush tip.The pull wire was returned kinked and detached from the handle.Lastly, the working length was found damaged (smashed).No other issues were noted.The reported event was confirmed.It is possible that the pull wire was detached from the handle due to procedural factors such as lesion characteristics, handling of the device, and the technique used by the physician (force applied).Based on all available information, adverse event related to procedure was selected as the most probable cause.

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 wire connected to the handle suddenly broke.Another rx cytology brush was used to complete the procedure.No further information has been obtained despite good faith efforts.There were no patient complications reported as a result of this event.Note: this event has been deemed reportable based on the investigation finding of brush detachment.Please see block h10 for full investigation details.

Manufacturer Narrative

Block h2: correction: block h10 device analysis updated to report labeling review.Block h6: imdrf device code a0501 captures the reportable investigation result of brush detachment.Block h10: investigation results the returned rx cytology brush was analyzed, and a visual evaluation noted that the device returned without the brush tip.The pull wire was returned kinked and detached from the handle.Lastly, the working length was found damaged (smashed).No other issues were noted.The reported event was confirmed.It is possible that the pull wire was detached from the handle due to procedural factors such as lesion characteristics, handling of the device, and the technique used by the physician (force applied).Based on all available information, adverse event related to procedure was selected as the most probable cause.A labeling review was performed and, from the information available, this device was used per the instructions for use (ifu)/product label.

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 wire connected to the handle suddenly broke.Another rx cytology brush was used to complete the procedure.No further information has been obtained despite good faith efforts.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: 18803657
• MDR Text Key: 337313081
• Report Number: 3005099803-2024-00703
• Device Sequence Number: 1
• Product Code: FDX
• UDI-Device Identifier: 08714729268628
• UDI-Public: 08714729268628
• Combination Product (y/n): N
• Reporter Country Code: KS
• 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: 03/28/2024

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
• Device Operator: Health Professional
• Device Model Number: M00545000
• Device Catalogue Number: 4500
• Device Lot Number: 0031977518
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/19/2024
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/05/2024
• Initial Date FDA Received: 02/28/2024
• Supplement Dates Manufacturer Received: 03/06/2024
• Supplement Dates FDA Received: 03/28/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/10/2023
• 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