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 11/22/2023

Event Type  malfunction  

Manufacturer Narrative

Block e1: (b)(6) university.Block h6: imdrf device code a0401 captures the reportable event of brush detachment.

Event Description

It was reported to boston scientific corporation that an rx cytology brush was used during an endoscopic retrograde cholangiopancreatography (ercp) procedure on (b)(6), 2023.During the procedure, the tip of the biliary brush was damaged and had a gap while the patient was being treated for upper abdominal discomfort.However, the tip was not detached and did not fall inside the patient.The procedure was completed using another rx cytology brush.There were no patient complications reported as a result of this event.

Event Description

It was reported to boston scientific corporation that an rx cytology brush was used during an endoscopic retrograde cholangiopancreatography (ercp) procedure on (b)(6) 2023.During the procedure, the tip of the biliary brush was damaged and had a gap while the patient was being treated for upper abdominal discomfort.However, the tip was not detached and did not fall inside the patient.The procedure was completed using another rx cytology brush.There were no patient complications reported as a result of this event.

Manufacturer Narrative

Block e1: healthcare facility name: (b)(6).Block h6: imdrf device code a0401 captures the reportable event of brush detachment.Block h6: investigation results: the returned rx cytology brush was analyzed and showed that the working length was kinked.A functional test was performed and attempted to extend the brush out of the sheath; however, it would not extend due to several kinks found in the working channel.The reported event was not confirmed.No manufacturing deviations were found in the manufacturing process that could determine the reported event of brush detached.However, the technique applied to the device and excessive force could have contributed to the working length being kinked.Based on the analysis, adverse event related to procedure was selected as the most probable root cause for this complaint.

• 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: 18333141
• MDR Text Key: 330584844
• Report Number: 3005099803-2023-06633
• Device Sequence Number: 1
• Product Code: FDX
• 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: 02/07/2024

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: 0030801626
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/23/2023
• Initial Date FDA Received: 12/14/2023
• Supplement Dates Manufacturer Received: 01/16/2024
• Supplement Dates FDA Received: 02/08/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/06/2023
• 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
• Patient Age: 58 YR
• Patient Sex: Male
• Patient Weight: 77 KG