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

Model Number	M00537190
Medical Device Problem Code	Kinked (1339)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).A visual evaluation of the returned device found that the stent was kinked at about 1 cm from the distal tip (pig tail section).A functional analysis was performed and found that the guidewire was stuck at the kinked section of the stent.Based on the product analysis, most likely some procedural/anatomical factors were encountered during the procedure which may have limited the overall performance of the device.A device under tortuous conditions due to patient anatomy or customer use/manipulation/maneuvering can cause the delivery system/stent to bend / coil leading to kinks and bends in the device.Moreover, it is most likely that the kinked encountered could have affected the device performance (guidewire stuck at kinked section).Therefore, ¿operational context¿ is selected as the most probable root cause for the complaint.A review of the device history record (dhr) confirms that the accepted device met all manufacturing specifications.A search of the complaint database confirmed that no similar complaints exist for the specified batch.
Event or Problem Description
It was reported to boston scientific corporation that an advanix pancreatic stent was used during pancreatic duct stenting procedure in pancreatic duct (exact date not reported).According to the complainant, during the procedure, it was observed that the guidewire was stuck on the delivery system during insertion.The procedure was completed with another advanix¿ biliary stent.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 "no injury".This event has been deemed a reportable event based on the investigation results; stent kinked.

• 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: 6339038
• Report Number: 3005099803-2017-00355
• Device Sequence Number: 1564000
• Product Code: FGE
• UDI-Device Identifier: 08714729856665
• UDI-Public: (01)08714729856665(17)20171231(10)0019339882
• 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): 01/25/2017

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: 12/31/2017
• Device Model Number: M00537190
• Device Catalogue Number: 3719
• Device Lot Number: 0019339882
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/06/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/25/2017
• Initial Report FDA Received Date: 02/17/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1