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

Model Number M00545000

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Reported event of wire broke.Analysis of the returned rx cytology brush revealed that the working length was kinked in multiple places throughout.The catheter was torn near the distal end of heat shrink and a loop of pull wire was exposed at this tear.The tear was not consistent with those caused by guide wires.The brush was missing.Functional evaluation found the thumb ring could be extended and retracted normally while the brush would not extend or retract.The exposed pull wire would slacken and bulge outside of the catheter when the thumb ring was extended.Retracting the thumb ring would cause the exposed pull wire to tighten and the catheter would bend and kink at the tear.The device was disassembled and the pull wire was found to be broken.It is possible that the catheter was kinked due to some aspects of handling during shipping, storage, unpacking, or preparation.Once the catheter was kinked, the pull wire would be prevented from moving freely inside the catheter.Further attempts to extend and retract the handle may have caused the pull wire to cut through the catheter at the heat shrink.Therefore, the most probable root cause for this event is determined to be operational context.A review of the device history record (dhr) was performed and no deviations were found.

Event Description

It was reported to boston scientific corporation that an rx cytology brush was used in the mid bile duct during an endoscopic cytodiagnosis procedure.According to the complainant, during the procedure the physician attempted to push and pull the thumb ring but the brush stopped moving.In addition, the device failed to retract into the catheter.The procedure was completed with the another 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 be good.This event has been deemed a reportable event based on the investigation results showing that the pull wire was broken.

• 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: 5414026
• MDR Text Key: 37613497
• Report Number: 3005099803-2016-00174
• 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
• Report Date: 01/13/2016

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: 06/30/2017
• Device Model Number: M00545000
• Device Catalogue Number: 4500
• Device Lot Number: 18144189
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/11/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/13/2016
• Initial Date FDA Received: 02/05/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/14/2015
• 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