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 11/06/2013

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 a diagnostic procedure performed on (b)(6), 2013.It was reported that the handle cannula bent.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 okay.This event has been deemed a reportable event based on the investigation results; brush bent.

Manufacturer Narrative

(b)(4).Investigation results: visual evaluation of the device found kinks and bends along the working length and handle cannula, and paint was peeled off at the distal end of the device.Functional testing revealed that the brush could only partially extend and retract.The complaint that the handle cannula was bent was confirmed.Manipulation of the device during the procedure likely caused the bent/kinked working length and the bent brush.Bends and kinks in the working length could lead to difficulty actuating the handle, which will eventually cause the handle cannula to bend.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.  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: 3561562
• MDR Text Key: 4057174
• Report Number: 3005099803-2014-00178
• Device Sequence Number: 1
• Product Code: FDX
• Combination Product (y/n): N
• Reporter Country Code: BE
• 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: 12/20/2013

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: Health Professional
• Device Expiration Date: 01/02/2015
• Device Model Number: M00545000
• Device Catalogue Number: 4500
• Device Lot Number: 15771499
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/14/2013
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/20/2013
• Initial Date FDA Received: 01/08/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/09/2013
• 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