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 11/18/2013

Event Type  malfunction  

Event Description

It was reported to boston scientific corporation that an rx cytology brush was prepared for use in the bile duct during a cytoscreening procedure on (b)(6) 2013.According to the complainant, during preparation, the physician attempted to retract the brush back into the sheath but met some resistance.Therefore, he replaced it with another rx cytology brush which 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 a reportable event based on the investigation results; brush bent.

Manufacturer Narrative

(b)(4) brush bent.Investigation results: visual evaluation of the returned device found several kinks along the working length, and paint was peeled off from the distal end of the extrusion.It was noted that the brush and handle cannula were bent.Functional evaluation was done and found the brush could extend without issue, but would only partially retract due to the kinks and bent brush.The complaint that the brush was difficult to retract was confirmed.It is likely that handling of the device during preparation caused the kinks and bent brush, which would ultimately cause difficulty retracting the brush.Continued efforts to retract the brush could bend the handle cannula.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.

• 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: 3602008
• MDR Text Key: 4092739
• Report Number: 3005099803-2014-00340
• 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: 01/07/2014

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: 11/29/2013
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/07/2014
• 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