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

Model Number M00545000

Device Problem Break (1069)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/27/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4) wire broke.Analysis of the returned rx cytology brush revealed multiple bends in the working length and the pull wire had become unwound and broken at the end of the hypotube.The brush bristle section was not returned.Functional analysis showed that the handle thumb ring could be extended and retracted with strong resistance and scraping inside handle t-fitting, however the pull wire would not move and brush bristle section would not extend.The event was most likely caused by some operational or anatomical 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 broken pull wire.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.

Event Description

It was reported to boston scientific corporation that an rx cytology brush was used in the bile duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2015.According to the complainant, during the procedure, the brush was fed over dreamwire into the bile duct through stricture and when the orange handle was pulled back, the tension was lost.Upon removal of the device, the brush was still extended out of the catheter even if the handle was pulled back completely.The handle pull wire had snapped.The procedure was completed with the same 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 okay.Attempts to obtain additional information regarding this event have been unsuccessful to date.Should additional relevant details become available, a supplemental report will be submitted.This event has been deemed a reportable event based on the investigation results; wire broke.

• 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 ; 780 brookside drive; spencer, IN 47460 ; 8128294877
• MDR Report Key: 5455238
• MDR Text Key: 38856491
• Report Number: 3005099803-2016-00486
• Device Sequence Number: 1
• Product Code: FDX
• Combination Product (y/n): N
• Reporter Country Code: GB
• 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
• Report Date: 01/29/2016

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: 18278174
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/18/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/29/2016
• Initial Date FDA Received: 02/23/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/18/2015
• 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