MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION NAVIFLEX RX DELIVERY SYSTEM; CATHETER, BILIARY, DIAGNOSTIC

Model Number	3506
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/09/2018
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 in a pancreatic duct stent placement performed in the pancreatic duct on (b)(6) 2018.According to the complainant, when they attempted to place the 7fr 9cm advanix pancreatic stent for chronic pancreatitis, the stent kinked which causes the deployment failure.The procedure was completed with a different device manufacturer and different size successfully.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Problem code 2976 captures the reportable event of stent kinked.A visual evaluation of the returned advanix pancreatic without its stent was performed and found that there were no visual defects noted, the returned product looks under good conditions without evidence of damages or anomalies.A function inspection was performed, although the stent involved was not returned for inspection, the pull wire was pulled and the guide catheter could be completely retracted which is evidence that probably the stent was able to be deployed properly during the use of the product.Therefore, no problem detected is selected for the most probable cause for the complaint.A dhr (device history record) review was performed and no deviation was found.
Event or Problem Description
It was reported to boston scientific corporation that an advanix pancreatic stent was used in a pancreatic duct stent placement performed in the pancreatic duct on (b)(6) 2018.According to the complainant, when they attempted to place the 7fr 9cm advanix pancreatic stent for chronic pancreatitis, the stent kinked which causes the deployment failure.The procedure was completed with a different device manufacturer and different size successfully.There were no patient complications reported as a result of this event.

• Brand Name: NAVIFLEX RX DELIVERY SYSTEM
• Common Device Name: CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 8143875
• Report Number: 3005099803-2018-61814
• Device Sequence Number: 215764
• Product Code: FGE
• UDI-Device Identifier: 08714729856221
• UDI-Public: 08714729856221
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 01/11/2019

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: 03/24/2020
• Device Model Number: 3506
• Device Catalogue Number: 3506
• Device Lot Number: 0022710554
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/04/2018
• Initial Date Received by Manufacturer: 11/12/2018
• Supplement Date Received by Manufacturer: 12/18/2018
• Initial Report FDA Received Date: 12/07/2018
• Supplement Report FDA Received Date: 01/11/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1