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

Model Number	M00536540
Medical Device Problem Code	Kinked (1339)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/22/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device code relates to problem code for the reported event of "stent kinked".A visual evaluation of the returned device found that the proximal tip is damaged and it is kinked/ severely damaged approximately at 4cm from the proximal end of the stent.Based on the product analysis, it is most likely that some procedural / anatomical factors were encountered during the procedure which may have limited the overall performance of the device.A device under tortuous condition due to patient anatomy or customer use/manipulation/maneuvering can cause the stent kinked, this condition can cause issues to advance the stent through the scope and continued efforts to advance the stent could have caused the damages found on the stent.Therefore, ¿operational context¿ is selected as the most probable root cause for the complaint.The device history record review found the device met all manufacturing specifications.A search of the complaint database revealed that no similar complaints exist for the specified lot.
Event or Problem Description
It was reported to boston scientific corporation that an advanix¿ pancreatic stent was placed into during a pancreatic duct stent placement procedure performed on (b)(6) 2017.According to the complainant, the stent was inserted endoscopically into the pancreatic duct through the guidewire, however severe resistance was felt at the mid-way.The procedure was completed with another advanix¿ pancreatic 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/bent.

• Brand Name: ADVANIX¿ PANCREATIC STENT
• Common Device Name: CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): BOSTON SCIENTIFIC - SPENCER; 780 brookside drive; spencer IN 47460
• MDR Report Key: 7165804
• Report Number: 3005099803-2017-03863
• Device Sequence Number: 1786360
• Product Code: FGE
• UDI-Device Identifier: 08714729857488
• UDI-Public: 08714729857488
• 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): 12/13/2017

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: 04/04/2019
• Device Model Number: M00536540
• Device Catalogue Number: 3654
• Device Lot Number: 0021222926
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/27/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/13/2017
• Initial Report FDA Received Date: 01/04/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1