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

Model Number M00545000

Device Problems Bent (1059); Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/24/2013

Event Type  malfunction  

Event Description

It was reported to boston scientific corporation that an rx cytology brush was used in the common bile duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2013.According to the complainant, during the procedure, the brush was unable to retract back into the sheath after collecting some tissue.It was also reported that the brush was tested prior to use and anatomy was not tortuous.Another rx cytology brush was used to complete the procedure.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 and wire broke.

Manufacturer Narrative

Investigation findings: brush bent.Investigation findings: wire broke.Investigation results visual evaluation of the device found the brush fully extended and bent.The working length was bent in several locations throughout.The extrusion tip was torn and had paint missing, possibly from abrasion with the bent pull wire.Functional testing was done by attempting to retract the brush.No resistance was felt; however, the brush and pull wire did not move.The device was disassembled and it was observed that the pull wire had detached from the handle cannula.The complaint that the brush was unable to retract was confirmed.Manipulation of the device during the procedure could cause the working length and the brush to bend, which would not allow the pull wire to move freely inside the sheath.Continued attempts to actuate the device can cause the pull wire to detach from the handle cannula, preventing subsequent retraction.Therefore, the most probable root cause of the identified failures 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.

• 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: 3566533
• MDR Text Key: 4213518
• Report Number: 3005099803-2014-00069
• 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: 12/17/2013

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: 08/13/2015
• Device Model Number: M00545000
• Device Catalogue Number: 4500
• Device Lot Number: 16304293
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/05/2013
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/17/2013
• Initial Date FDA Received: 01/09/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/21/2013
• 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