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

Model Number	M00537330
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).The device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental mdr will be filed.
Event or Problem Description
It was reported to boston scientific corporation that an advanix pancreatic stent was used during pancreatic duct stent placement procedure performed in the pancreatic duct (exact date not reported).According to the complainant, when they attempted to deploy the stent, guidewire was placed in the pancreatic duct.However, resistance was felt from the midpoint and it was unable to advance any further so the device was retrieved.When they retrieved the advanix pancreatic stent, the stent tip on the distal side was found to be ¿damaged¿.The procedure was completed by placing another advanix pancreatic stent.There were no patient complications reported as a result of this event.The patient's condition was reported to be "good".
Additional Manufacturer Narrative
A visual evaluation of the returned device found that the distal section of the stent is severely damaged, also it is slightly bent/curved in the middle, the stent presents damages in several locations.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 bend and damage the stent, also anatomical factors and the device condition could have resulted in issues of interaction with the guidewire and stent/delivery system.Therefore, ¿operational context¿ is selected as the most probable root cause for the complaint.A dhr (device history record) review was performed and no deviation was found.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 used during pancreatic duct stent placement procedure performed in the pancreatic duct (exact date not reported).According to the complainant, when they attempted to deploy the stent, guidewire was placed in the pancreatic duct.However, resistance was felt from the midpoint and it was unable to advance any further so the device was retrieved.When they retrieved the advanix pancreatic stent, the stent tip on the distal side was found to be ¿damaged¿.The procedure was completed by placing another advanix pancreatic stent.There were no patient complications reported as a result of this event.The patient's condition was reported to be "good".

• 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: 6858805
• Report Number: 3005099803-2017-02738
• Device Sequence Number: 809702
• Product Code: FGE
• UDI-Device Identifier: 08714729856924
• UDI-Public: (01)08714729856924(17)20180430(10)19826904
• 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,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/22/2017

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: 04/30/2018
• Device Model Number: M00537330
• Device Catalogue Number: 3733
• Device Lot Number: 19826904
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/07/2017
• Initial Date Received by Manufacturer: 08/22/2017
• Supplement Date Received by Manufacturer: 08/22/2017
• Initial Report FDA Received Date: 09/12/2017
• Supplement Report FDA Received Date: 12/12/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1