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 used in the common bile duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2013.According to the complainant, during unpacking, a slight resistance was encountered but the device was still used.The brush was not able to retract after exfoliative cytodiagnosis was performed.The device was removed from the patient and was tested for retraction but still failed.No kinks on the working length were noted prior to use.The procedure was completed with this device.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 the handle cannula.

Manufacturer Narrative

(b)(4) drive wire detached from the handle cannula.Investigation results: visual evaluation of the returned device found that the drive wire had detached from the handle cannula.The area where the drive wire had detached had no signs of either stretching or tearing.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.No other visible anomalies were noticed externally.The brush was fully extended when it was received, and functional evaluation found brush was unable to retract.The complaint was confirmed; a device with a detached drive wire would not retract.The issue was identified during the procedure inside the patient.It is likely that the drive wire detached due to anatomical/ procedural factors; 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.

• 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: 3602408
• MDR Text Key: 4191085
• Report Number: 3005099803-2014-00551
• 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: 08/13/2015
• 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: 12/13/2013
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/16/2014
• Initial Date FDA Received: 01/31/2014
• 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