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

Model Number	M00537300
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/20/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Although the suspect device has been received, the evaluation has not been completed.Therefore, the cause of the reported malfunction has not been determined.Upon 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 on (b)(6) 2017.According to the complainant, after undergoing an operation (operation type not reported), the physician used a single balloon in the intestinal tract and attempted to place the advanix pancreatic stent in the pancreatic duct.Due to severe tortuosity up to the target area, when the physician tried to deploy the advanix pancreatic stent, the stent deformed into ¿bellow-like¿ shape without applying too much force to the stent.The device was removed from the patient since it was unable to be deployed, and the procedure was completed with a different device with no complications reported as a result of the event.
Additional Manufacturer Narrative
A visual evaluation of the returned device found that the push catheter and pull wire are kinked approximately at 28cm from the handle, the guide catheter is kink approximately at 22cm from the distal end of the guide catheter.The proximal section of the stent is deformed and it is bent approximately at 2.5cm from the distal end of the stent, also it was damaged in several locations.A functional evaluation for stent deployment was performed and found that as the pull wire was retracted, stent was push against the push catheter instead of being deployed.The device failed to deploy the stent.Based on the product analysis, most likely some operational/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 device to bend/coil leading to kink/bend the catheters, pull wire and the stent.With the catheters, pull wire and stent kinked/bent, the device would become difficult to deployed the stent, continued efforts to deploy the stent can lead to damage the stent since it is pushed against the push catheter instead of being deployed, since it gets stuck in the delivery system due to bending condition of both components.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 stent placement procedure performed in the pancreatic duct on (b)(6) 2017.According to the complainant, after undergoing an operation (operation type not reported), the physician used a single balloon in the intestinal tract and attempted to place the advanix pancreatic stent in the pancreatic duct.Due to severe tortuosity up to the target area, when the physician tried to deploy the advanix pancreatic stent, the stent deformed into ¿bellow-like¿ shape without applying too much force to the stent.The device was removed from the patient since it was unable to be deployed, and the procedure was completed with a different device with no complications reported as a result of the event.

• 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: 6339028
• Report Number: 3005099803-2017-00275
• Device Sequence Number: 13658660
• Product Code: FGE
• UDI-Device Identifier: 08714729856894
• UDI-Public: (01)08714729856894(17)20171231(10)19399593
• 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,Followup
• Report Date (Section B): 01/23/2017

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: M00537300
• Device Catalogue Number: 3730
• Device Lot Number: 19399593
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/30/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 01/23/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/17/2017
• Supplement Report FDA Received Date: 03/13/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1