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	12/17/2015
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Reported event of "stent kinked." the complainant indicated that the device remains implanted and will not be returned for evaluation; therefore, a failure analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental mdr will be filed.
Event or Problem Description
It was reported to boston scientific corporation that a commercial bsc plastic stent was implanted in the pancreatic duct of a patient on (b)(6) 2015 as part of the (b)(6) study.On (b)(6) 2015, the patient underwent the study stent placement procedure.An intraprocedural pancreatogram was recorded just before stent placement.A prior biliary and pancreatic sphincterotomy had been performed.The pancreatic duct was dilated 4mm and the stent is intended to be indwell for more than 8 weeks.During the stent placement, a 9 cm 7 fr straight with leading barbs advanix stent with lot number 18134488 was placed in a satisfactory manner.Overall ease of placement was poor, stent pushability was very poor and visualized fluoroscopically was good.According to the complainant, during procedure, it was noticed that the study stent was kinked however it was placed successfully.

• 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: 6327969
• Report Number: 3005099803-2017-00276
• Device Sequence Number: 773725
• Product Code: FGE
• UDI-Device Identifier: 08714729857488
• UDI-Public: (01)08714729857488(17)20161231(10)18134488
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K133700
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/20/2017

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: Physician
• Device Expiration Date: 12/31/2016
• Device Model Number: M00536540
• Device Catalogue Number: 3654
• Device Lot Number: 18134488
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/20/2017
• Initial Report FDA Received Date: 02/14/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 49 YR