MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION; ENDOSCOPIC CYTOLOGY BRUSH

Model Number M00545000

Device Problems Device Dislodged or Dislocated (2923); Material Integrity Problem (2978)

Patient Problem No Information (3190)

Event Date 11/24/2014

Event Type  malfunction  

Event Description

Devices being utilized in tandem: boston scientific rx cytology brush and navipro hydrophilic guidewire issue: while utilizing a wire guided cytology brush during an ercp procedure, the radiopaque marker ring from the tip of the cytology brush catheter was dislodged and left within a side branch bile duct in the liver.Concern: the navipro guidewire has recently been prone to loss of its hydrophilic lubricious coating.This sometimes culminates in friction induced tears or disruption of its outer plastic coat.In this case, while using a standard wire guided cytology brush catheter, the radio-opaque marker at the tip of the catheter became dislodged and left within the patient.Catheter inspection noted no evidence for tears in the plastic wire guidance lumen nor at the leading tip, hence neither inappropriate use of the wire or brush nor inappropriate removal of the catheter over the wire contributed to the malfunction.Inspection of the wire confirmed loss of slippery coating and a roughened surface.As the wire was gradually more resistant to device passage, it is the most likely cause of the loosening and disruption of the radiopaque ring.Manufacturer response for guidewire, rx cytology brush wireguided cytology brush used with navipro hydrophilic guidewire (per site reporter).
=
they are looking into the problems addressed.

• Type of Device: ENDOSCOPIC CYTOLOGY BRUSH
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 100 boston scientific way; marlborough, MA 01752
• MDR Report Key: 4373402
• MDR Text Key: 5234300
• Report Number: 4373402
• Device Sequence Number: 1
• Product Code: FDX
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Type of Report: Initial
• Report Date: 12/23/2014
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 12/23/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: M00545000
• Device Catalogue Number: 4500
• Device Lot Number: 17339619
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/23/2014
• Event Location: Other
• Date Report to Manufacturer: 12/31/2014
• Patient Sequence Number: 1
• Treatment: NO OTHER THERAPIES