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

Model Number M00545000

Device Problem Bent (1059)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/09/2014

Event Type  malfunction  

Event Description

It was reported to boston scientific corporation that an rx cytology brush was used in the bile duct during a cytotechnology procedure performed on (b)(6) 2014.According to the complainant, there were no issues with advancing the device to the stricture.However, strong resistance was felt when the physician tried to extend the brush out of the sheath; the physician had to exert more force than usual to extend the brush.It was noted that the endoscope was in a tortuous position, so the physician straightened the endoscope slightly, which seemed to alleviate the issue.Several brushes were performed, but it was reported that the resistance became stronger with each brushing.After the sixth brushing, strong resistance was felt once again.The physician attempted to retract the brush, but could not.When the handle was pulled forcibly, the orange thumb ring detached.As the device could not be retracted, the brush and the endoscope were removed together.The procedure was not completed due to this event.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.This event has been deemed a reportable event based on the investigation results: brush bent.

Manufacturer Narrative

Investigation result of brush bent.Investigation results: visual evaluation of the returned device found that the brush was bent, and the catheter and wire were kinked in multiple locations.The handle cannula and the orange thumb ring were separated from the t-fitting and were not returned.Functional evaluation could not be performed due to the condition of the returned device.The condition of the device was consistent with the complaint that the handle broke.However, the complaint that the brush was difficult to extend and retract could not be confirmed due to the condition of the returned device.It is likely that the working length and the brush became kinked due to anatomical/procedural factors encountered during the use of the device.Once the working length was kinked, it would have been difficult to actuate the brush.Forceful effort to actuate the brush could have caused separation of the handle components.Therefore, the most probable root cause for the failures identified is operational context.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.A search of the complaint database confirmed that no other complaints exist for the specified batch.

• 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: ingrid matte ; 100 boston scientific way; marlborough, MA 01752 ; 5086834000
• MDR Report Key: 3944613
• MDR Text Key: 4538310
• Report Number: 3005099803-2014-02542
• 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: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/26/2014

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: Physician
• Device Expiration Date: 12/04/2015
• Device Model Number: M00545000
• Device Catalogue Number: 4500
• Device Lot Number: 16585186
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/14/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/26/2014
• Initial Date FDA Received: 07/18/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/09/2013
• 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