MAUDE Adverse Event Report: BOSTON SCIENTIFIC - SPENCER ADVANIX¿ PANCREATIC STENT KIT; CATHETER, BILIARY, DIAGNOSTIC

Model Number	M00537470
Medical Device Problem Code	Kinked (1339)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/31/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient's exact age is unknown; however it was reported that the patient was over the age of 18.(b)(4).A visual evaluation of the returned device found that the stent is bent approximately at 3.5cm from the leading end.The pusher is kinked in several locations.The reported issue of stent deployed prematurely could not be functionally verified, however as per additional information the pusher was not out from the scope, so the guidewire was removed and the stent was detached in duodenum.The stent deployed prematurely since the customer removed the guidewire in an unintended location, it is considered as user error since the directions for use (90986261, dfu, mb, advanix pancreatic stent 3f-5f, bsc, aa) states "to fully deploy stent, unlock the guidewire from the boston scientific rx locking device, and completely retract guidewire into pusher.".It appears that the customer did not follow the directions for use, since the user failed to follow the sequence of steps outlined the dfu, it is considered user / use error.Additionally the reported issue of stent difficulty advancing through the scope could not be functionally verified and the stent and pusher outer diameter were found within specifications, however findings from visual evaluation indicates that likely there were issues advancing the device through the scope.Visual assessment identified both devices were kinked/bent and this condition could have caused issues advancing the device through the scope, also handling and manipulation of the devices during procedure can lead to kink/bend the devices, likely procedural or anatomical factors encountered during procedure could have affected the device performance and its integrity, therefore the most probable cause for the encountered issues is operational context, probably due to anatomical/procedural factors encountered during the procedure, performance was limited.All compiled information on this investigation determines that the most probable cause is: user / use error.A dhr (device history record) review was performed and no deviation was found.
Event or Problem Description
It was reported to boston scientific corporation that an advanix pancreatic stent kit was used during an endoscopic retrograde cholangiopancreatography procedure in the pancreatic duct, performed on (b)(6) 2018.According to the complainant, during the procedure, the physician attempted to place the stent in to the pancreatic duct but the push catheter and the stent did not come out from the scope channel of the endoscope.The physician removed the guidewire and the stent was detached in the duodenum which was retrieved using a forceps.The procedure was completed without placing the stent.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; stent kinked.

• Brand Name: ADVANIX¿ PANCREATIC STENT KIT
• Common Device Name: CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): BOSTON SCIENTIFIC - SPENCER; 780 brookside drive; spencer IN 47460
• MDR Report Key: 7349236
• Report Number: 3005099803-2018-00731
• Device Sequence Number: 784975
• Product Code: FGE
• UDI-Device Identifier: 08714729856252
• UDI-Public: 08714729856252
• Combination Product (Y/N): N
• PMA/510(K) Number: K133700
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/22/2018

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
• Operator of Device: Health Professional
• Device Expiration Date: 12/31/2018
• Device Model Number: M00537470
• Device Catalogue Number: 3747
• Device Lot Number: 20929518
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/05/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/22/2018
• Initial Report FDA Received Date: 03/19/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1