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

Model Number M00545000

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/30/2020

Event Type  malfunction  

Manufacturer Narrative

(initial reporter city): (b)(6).(b)(4).The device has not been received for analysis; therefore, a failure analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.

Event Description

It was reported to boston scientific corporation that an rx cytology brush was opened and used to diagnose a lower common bile duct stenosis in the lower common bile duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2020.According to the complainant, during the procedure, the physician found the tip of the brush would not extend from the catheter and that the outer sheath of the delivery shaft was damaged.The procedure was completed with another rx cytology brush.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to stable.

Event Description

It was reported to boston scientific corporation that an rx cytology brush was opened and used to diagnose a lower common bile duct stenosis in the lower common bile duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6), 2020.According to the complainant, during the procedure, the physician found the tip of the brush would not extend from the catheter and that the outer sheath of the delivery shaft was damaged.The procedure was completed with another rx cytology brush.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to stable.

Manufacturer Narrative

Block e1 (initial reporter city): (b)(6) block h6: problem code 2907 captures the reportable event of working length detached/separated.Block h10: investigation results one rx cytology brush was received for analysis.Visual inspection of the returned device revealed that the working length (extrusion and pull wire) was kinked at the proximal section, approximately at 44cm and 45cm from the black heat shrink.However, no broken nor detached section were found along the device.Functional evaluation of the returned device found that when the handle was actuated, the brush did not extend.The handle was disassembled (the blue cap was unscrewed) and it was observed that the pull wire was kinked at the proximal end (the distal end of the handle cannula).This device condition could have generated the issues during brush extension.Therefore, the reported complaint of brush difficult to extend is confirmed.Based on all available information, boston scientific concludes that this device met all manufacturing requirements and no abnormalities were reported during the manufacturing process.During the visual assessment, it was found that the working length and the pull wire were kinked.As per complaint information the issue occurred during the procedure.It is most likely that the failures found were caused due to manipulation as the customer brushed back and forth during the procedure.Handling and manipulation of the device can lead to kink along the catheter.This condition can cause difficulties to extend the brush due to the resistance between the components at the kinked sections of the device.Force applied to the handle in order to extend the brush can result in kinks along the pull wire at the distal end of the handle cannula.Based on the information available and the analysis performed, the most probable root cause classification is adverse event related to procedure.However, a cause of no problem detected is assigned to the reported complaint issue of working length detachment of device or device component, since the returned device showed no evidence of either the alleged issue or any defect which could have contributed with this event.A review of the device history record (dhr) was performed and confirmed that this device met all material, assembly and performance specifications at the time of release for distribution.A labelling review was performed and, from the information available, this device was used per the directions for use (dfu) / product label.There were no issues found with the translation, wording, or graphics in the dfu.

• Brand Name: RX CYTOLOGY BRUSH
• Type of Device: ENDOSCOPIC CYTOLOGY BRUSH
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 10320210
• MDR Text Key: 200263968
• Report Number: 3005099803-2020-02952
• Device Sequence Number: 1
• Product Code: FDX
• UDI-Device Identifier: 08714729268628
• UDI-Public: 08714729268628
• Combination Product (y/n): N
• PMA/PMN Number: K930348
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 08/27/2020

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 Expiration Date: 02/28/2021
• Device Model Number: M00545000
• Device Catalogue Number: 4500
• Device Lot Number: 0023422597
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/22/2020
• Initial Date Manufacturer Received: 07/01/2020
• Initial Date FDA Received: 07/24/2020
• Supplement Dates Manufacturer Received: 08/05/2020
• Supplement Dates FDA Received: 08/27/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 66 YR
• Patient Weight: 72