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

Model Number M00545000

Device Problem Detachment of Device or Device Component (2907)

Patient Problems Fever (1858); No Code Available (3191)

Event Date 08/19/2020

Event Type  Injury  

Manufacturer Narrative

The patient's weight is (b)(6).(b)(4).The device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.

Event Description

It was reported to boston scientific corporation that an rx cytology brush was used in the front area of the bile duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2020.According to the complainant, during the procedure, when scraping cytology was performed using this device, it was noticed that the radio-opaque (ro) marker did not move even when manipulating the brush midway.When the brush was pulled together with the catheter from the endoscope, it was noticed that there was no ro marker on the tip.It was confirmed by fluoroscopy that the marker was displayed in the body.The physician was unable to collect the ro marker on that day.It was reported that future treatment is yet to be determined.The procedure was completed with this device and the patient was reported to be stable at that time.There was an ro marker in the periphery of the intrahepatic bile duct, which made recovery difficult.Endoscopic nasobiliary drainage (enbd) can be placed on the same branch.However, cholangitis was not controlled.The patient experienced fever and poor nutrition due to the uncontrolled cholangitis.

Manufacturer Narrative

Block a4: the patient's weight is 50.4 kg.Block e1: the initial reporter address is (b)(6).Block h6: problem code 2907 captures the reportable event of ro marker detached.Problem code 3191 captures the reportable event of cholangitis.Problem code 1858 captures the reportable event of fever.Block h10: (product investigation) the returned rx cytology brush was analyzed, and a visual evaluation noted that the brush was returned partially retracted.It was also found that the bullet was detached and it was not returned for analysis.However, the r/o marker was properly found in its position, and was not detached nor abnormalities were found during the testing.A functional evaluation noted that when the handle was actuated, the brush was unable to extend/retract normally.The device was disassembled (the blue cap was unscrewed) and it was observed that the pull wire was broken at the proximal end (distal end of the handle cannula).No other issues with the device were noted.The reported event was not confirmed.During the visual assessment, it was found that the r/o marker was properly in its position, and was not detached nor abnormalities were found during the testing.Therefore, a cause of no problem detected is assigned to the reported complaint issue of ro marker band detachment of device or device component issue.A review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.A search of the complaint database confirmed that no similar complaints exist for the specified lot.A labeling review was performed and, from the information available, this device was used per the directions for use (dfu) / product label.

Event Description

It was reported to boston scientific corporation that an rx cytology brush was used in the front area of the bile duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2020.According to the complainant, during the procedure, when scraping cytology was performed using this device, it was noticed that the radio-opaque (ro) marker did not move even when manipulating the brush midway.When the brush was pulled together with the catheter from the endoscope, it was noticed that there was no ro marker on the tip.It was confirmed by fluoroscopy that the marker was displayed in the body.The physician was unable to collect the ro marker on that day.It was reported that future treatment is yet to be determined.The procedure was completed with this device and the patient was reported to be stable at that time.There was an ro marker in the periphery of the intrahepatic bile duct, which made recovery difficult.Endoscopic nasobiliary drainage (enbd) can be placed on the same branch.However, cholangitis was not controlled.The patient experienced fever and poor nutrition due to the uncontrolled cholangitis.

• 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: 10518030
• MDR Text Key: 206776168
• Report Number: 3005099803-2020-03821
• 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: 11/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/10/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/24/2022
• Device Model Number: M00545000
• Device Catalogue Number: 4500
• Device Lot Number: 0025259779
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/07/2020
• Date Manufacturer Received: 10/07/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 57 YR