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 11/27/2013

Event Type  malfunction  

Event Description

It was reported to boston scientific corporation that an rx cytology brush was opened during a cytological brushing procedure performed on (b)(6) 2013.According to the complainant, during preparation, the brush did not to extend from the sheath.The physician then decided to bend the distal end of the catheter which enabled the brush to come out of the sheath.However, the physician decided to stop using the brush and used another rx cytology brush 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; drive wire detached from handle cannula.

Manufacturer Narrative

(b)(4).Visual evaluation of the returned device found the brush fully extended.When the handle was manipulated, the brush would not retract.The handle was disassembled and it was found that the drive wire had detached from the handle cannula.No signs of stretching or tearing were seen from where the drive wire detached.No remainder of the drive wire was found in the handle cannula, which indicates that the drive wire was pulled out of the cannula.The distal end of the handle cannula was flattened from crimping to secure the connection between the cannula and the drive wire.There were no signs that the device was altered at the distal end of the catheter.The complaint that the brush failed to extend could not be verified due to the detached drive wire in the handle cannula.The drive wire detachment likely occurred prior to or during testing; therefore, the most probable root cause of the issues found is handling damage.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 revealed that no similar complaints exist for the specified lot.

• 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: 3619753
• MDR Text Key: 4171192
• Report Number: 3005099803-2014-00820
• 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: 01/16/2014

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: 08/09/2015
• Device Model Number: M00545000
• Device Catalogue Number: 4500
• Device Lot Number: 16298307
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/03/2013
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/16/2014
• Initial Date FDA Received: 02/10/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/23/2013
• 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