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

Model Number M00545000

Device Problem Detachment Of Device Component (1104)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/27/2016

Event Type  malfunction  

Manufacturer Narrative

Patient's exact age is unknown; however it was reported that the patient was over the age of 18.(b)(4).Although the suspect device has been received, the evaluation has not been completed.Therefore, the cause of the reported malfunction has not been determined.Upon completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental mdr will be filed.

Event Description

It was reported to boston scientific corporation that an rx cytology brush was used in the bile duct during a biopsy procedure performed on (b)(6) 2016.According to the complainant, during the procedure, the physician attempted to brush the bile duct.When tissue was obtained, the device was removed while leaving the guide wire and tube stent extended.Fluoroscopy showed that a radiopaque marker remained inside the patient.The radioopaque marker was detached from the brush and was passed naturally after the deployment of metallic stent.The procedure was completed with this device.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 be good.

Manufacturer Narrative

Investigation results: visual analysis of the returned rx cytology brush revealed that the catheter guidewire lumen was torn through from the distal u-channel marker to the catheter distal dip.The ro marker was missing and the brush was in retracted position.Functional evaluation found brush would fully extend and retract without difficulty.The brush bristle section of the wire had been cut and was not returned.The complaint that the radiopaque marker detached was confirmed.Based on the product analysis, most likely the customer did not follow the guidance in device removal section of the directions for use, which instructs the user to perform a standard device exchange.In this case it appears the user performed a tear-away exchange; therefore, the most probable root cause for the reported complaint is user/use error.A review of the device history record (dhr) confirmed that the device met all material, assembly, and product specifications at the time of release to distribution.

Event Description

It was reported to boston scientific corporation that an rx cytology brush was used in the bile duct during a biopsy procedure performed on (b)(6) 2016.According to the complainant, during the procedure, the physician attempted to brush the bile duct.When tissue was obtained, the device was removed while leaving the guide wire and tube stent extended.Fluoroscopy showed that a radiopaque marker remained inside the patient.The radioapaque marker was detached from the brush and was passed naturally after the deployment of metallic stent.The procedure was completed with this device.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 be good.

• Brand Name: RX CYTOLOGY BRUSH
• Type of Device: ENDOSCOPIC CYTOLOGY BRUSH
• Manufacturer (Section D): BOSTON SCIENTIFIC - SPENCER; 780 brookside drive; spencer IN 47460
• Manufacturer (Section G): BOSTON SCIENTIFIC - SPENCER; 780 brookside drive; spencer IN 47460
• Manufacturer Contact: nancy cutino ; 100 boston scientific way; marlborough, MA 01752 ; 5086834000
• MDR Report Key: 5670312
• MDR Text Key: 45626249
• Report Number: 3005099803-2016-01288
• Device Sequence Number: 1
• Product Code: FDX
• 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
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/27/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/20/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 06/30/2017
• Device Model Number: M00545000
• Device Catalogue Number: 4500
• Device Lot Number: 18169972
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/06/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/03/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/08/2015
• 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