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 10/30/2013

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 ercp (endoscopic retrograde cholangiopancreatography) procedure performed on (b)(6) 2013.According to the complainant, the ampulla was cannulated without issue.However, during preparation of the brush, the scrub sister noticed that the brush was unable to fully retract.The physician inserted the brush into the endoscope, and observed that the brush was not inside the sheath when it exited the endoscope.As it would not be possible to cannulate the cbd with the brush extended, 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 stable.This event has been deemed reportable based on the investigation results: brush bent.

Manufacturer Narrative

(b)(4) brush bent.Visual evaluation showed kinks along the working length.In addition the brush was bent, and paint was peeled off at the distal end of the extrusion.Functional testing revealed that the brush could only partially retract due to the kinks and bent brush.The complaint that the brush failed to retract fully was confirmed.Manipulation of the device during preparation could have caused the bent brush and kinked working length, which would impede subsequent attempts to retract the device.Therefore, the most probable root cause of the identified failures 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: 3572777
• MDR Text Key: 4037971
• Report Number: 3005099803-2014-00102
• Device Sequence Number: 1
• Product Code: FDX
• Combination Product (y/n): N
• Reporter Country Code: ZA
• 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: Nurse
• Device Expiration Date: 05/21/2015
• Device Model Number: M00545000
• Device Catalogue Number: 4500
• Device Lot Number: 16110003
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/22/2013
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/20/2013
• Initial Date FDA Received: 01/13/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/23/2013
• 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
• Patient Age: 56 YR
• Patient Weight: 90