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 11/07/2013

Event Type  malfunction  

Manufacturer Narrative

Exact patient age is unknown but is over 18 years.(b)(4) drive wire separated from handle cannula.Investigation results: visual evaluation of the returned device found that the drive wire had separated from the handle cannula.The area where the drive wire had detached had no signs of either stretching or tearing.The working length had no kinks.No remainder of the drive wire was found inside the handle cannula, indicating the drive wire had been pulled out of the cannula.The distal end of the handle cannula was flattened from crimping process that secures the connection between the cannula and the drive wire.A functional evaluation could not be performed due to the detached drive wire.The complaint was confirmed; a device with a detached drive wire would not retract.As evidence was found that the device was assembled properly during manufacturing, it is more likely that procedural and anatomical factors involved in the procedure could cause the drive wire detachment.Therefore, the most probable root cause of the defects 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.

Event Description

It was reported to boston scientific corporation that an rx cytology brush was used in the common bile duct during a cytology procedure on (b)(6) 2013.According to the complainant, during the procedure, the physician was unable to retract the brush.The procedure was completed with another rx 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 reportable based on the investigation finding: drive wire detached from the handle cannula.

• 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: 3571996
• MDR Text Key: 15983677
• Report Number: 3005099803-2014-00219
• 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: 12/19/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/13/2014
• 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: 11/15/2013
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/19/2013
• 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