MAUDE Adverse Event Report: BOSTON SCIENTIFIC - SPENCER RX CYTOLOGY BRUSH; ENDOSCOPIC CYTOLOGY BRUSH

Model Number M00545000

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/14/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Analysis of the returned rx cytology brush revealed the working length which includes catheter and pull wire had been kinked.During functional test, the device was unable to extend.Device handle was disassembled and assessment found the pull wire had been broken from the hypotube.The most probable root cause for this event is determined to be operational context since residue on the bristles indicates that the device was used in the procedure and the issue was likely due to anatomical and/or procedural factors.A review of the device history record (dhr) was performed and no deviations were found.A search of the complaint database revealed that no other complaints exist for the specified lot.

Event Description

It was reported to boston scientific corporation that an rx cytology brush was used in the common bile duct during a scraping cytology procedure performed on (b)(6) 2016.According to the complainant, during preparation, the device was difficult to extend.The procedure was completed with another rx cytology brush.There were no patient complications reported as a result of this event.This event has been deemed a reportable event based on the investigation results; the pull wire was broken.

Manufacturer Narrative

(b)(4).

Event Description

It was reported to boston scientific corporation that an rx cytology brush was used in the common bile duct during a scraping cytology procedure performed on (b)(6) 2016.According to the complainant, during preparation, the device was difficult to extend.The procedure was completed with another rx cytology brush.There were no patient complications reported as a result of this event.This event has been deemed a reportable event based on the investigation results; the pull wire was broken.

• 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: nancy cutino ; 100 boston scientific way; marlborough, MA 01752 ; 5086834000
• MDR Report Key: 6207609
• MDR Text Key: 63368928
• Report Number: 3005099803-2016-03948
• 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: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/08/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/27/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2018
• Device Model Number: M00545000
• Device Catalogue Number: 4500
• Device Lot Number: 19631462
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/18/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/27/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/30/2016
• 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