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	12/01/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient's exact age is unknown; however it was reported that the patient was over the age of 18.(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
Note: this report pertains to one of three devices used during the same procedure.Refer to manufacturer report # 3005099803-2017-03865, 3005099803-2017-03869, 3005099803-2017-03866 for the associated device information.It was reported to boston scientific corporation that an advanix pancreatic stent was used during an endoscopic retrograde cholangio-pancreatography procedure performed on (b)(6) 2017.As the physician introduced a 7frx 11cm advanix pancreatic stent into the patient¿s pancreatic duct, he experienced some resistance.The stent was advanced into position and when the technician attempted to deploy the stent the delivery system and advanix pancreatic stent both buckled/crunched up which would not allow the stent to release from the catheter.The device was removed from the scope.They then attempted to place a 5frx9cm advanix pancreatic stent over a guidewire and push it into position with a hydratome.During the advancing of the 5frx9cm advanix pancreatic stent, it too buckled and had to be removed.Finally, a naviflex pancreatic delivery system was loaded with the 7frx9cm advanix pancreatic stent and attempted to be pushed into position.The stent was in position and the delivery system buckled during deployment.The physician had to use the elevator of the scope to pinch/hold the end of the stent in place during the deployment.The procedure was completed after placing the 7frx9cm advanix pancreatic 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 fine.
Additional Manufacturer Narrative
A visual evaluation of the returned device was performed and found that the proximal section of the stent is severely damaged (bent/kinked).Based on product analysis, the issue occured during procedure, inside the patient, most likely that some procedural / anatomical factors were encountered during the procedure which may have limited the overall performance of the device.Device under tortuous condition due to patient anatomy or customer use/manipulation/maneuvering can cause the stent to bend / coil leading to kinks and bends in the device, continued efforts to implant the stent could have damaged the stent.Therefore, ¿operational context¿ is selected as the most probable root cause for the complaint.A review of the device history record (dhr) was performed no deviation was found.A search of the complaint database revealed that no similar complaints exist for the specified lot.
Event or Problem Description
This report pertains to one of three devices used during the same procedure.Refer to manufacturer report # 3005099803-2017-03865, 3005099803-2017-03869, 3005099803-2017-03866 for the associated device information.It was reported to boston scientific corporation that an advanix pancreatic stent was used during an endoscopic retrograde cholangio-pancreatography procedure performed on (b)(6) 2017.As the physician introduced a 7frx 11cm advanix pancreatic stent into the patient¿s pancreatic duct, he experienced some resistance.The stent was advanced into position and when the technician attempted to deploy the stent the delivery system and advanix pancreatic stent both buckled/crunched up which would not allow the stent to release from the catheter.The device was removed from the scope.They then attempted to place a 5frx9cm advanix pancreatic stent over a guidewire and push it into position with a hydratome.During the advancing of the 5frx9cm advanix pancreatic stent, it too buckled and had to be removed.Finally, a naviflex pancreatic delivery system was loaded with the 7frx9cm advanix pancreatic stent and attempted to be pushed into position.The stent was in position and the delivery system buckled during deployment.The physician had to use the elevator of the scope to pinch/hold the end of the stent in place during the deployment.The procedure was completed after placing the 7frx9cm advanix pancreatic 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 fine.

• 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: 7148570
• Report Number: 3005099803-2017-03869
• Device Sequence Number: 19201290
• Product Code: FGE
• UDI-Device Identifier: 08714729857488
• UDI-Public: 08714729857488
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K133700
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/01/2017

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: 02/26/2019
• Device Model Number: M00536540
• Device Catalogue Number: 3654
• Device Lot Number: 21074660
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/06/2017
• Initial Date Received by Manufacturer: 12/01/2017
• Supplement Date Received by Manufacturer: 01/03/2018
• Initial Report FDA Received Date: 12/27/2017
• Supplement Report FDA Received Date: 01/25/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1