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 11/11/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Investigation results: visual evaluation of the returned device showed that there were multiple bends and kinks throughout the working length.Functional evaluation found the brush would not extend.Device was disassembled.Assessment found one strand of the pull wire had been broken at about 4 mm from the hypotube.The bend and kinks in the working length were most likely due to some tortuous anatomical or some operational aspect of the procedure which restricted the pull wire¿s ability to move freely within the catheter.Attempts to extend and retract the brush with pull wire movement restricted resulted in the pull wire strand breaking at the hypotube.Therefore, the most probably root cause for this event is determined to be operational context.A review of the device history record (dhr) was performed; no anomalies were noted.A search of the complaint database confirmed 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 an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2015.According to the complainant, during the procedure the brush failed to come out from the sheath.The procedure was completed with another rx cytology brush.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 fine.This event has been deemed a reportable event based on the investigation results of pull wire 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: 5345099
• MDR Text Key: 35110767
• Report Number: 3005099803-2016-00005
• Device Sequence Number: 1
• Product Code: FDX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K930348
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/17/2015

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: Health Professional
• Device Expiration Date: 08/31/2017
• Device Model Number: M00545000
• Device Catalogue Number: 4500
• Device Lot Number: 18331798
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/17/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/17/2015
• Initial Date FDA Received: 01/05/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/09/2015
• 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