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

Model Number	M00535060
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/19/2018
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 a stenting procedure in the pancreatic duct, performed on (b)(6) 2018.According to the complainant, during the procedure, when the physician attempted to deploy the stent in the pancreatic duct, it was noticed that the stent was deformed.The procedure was successfully completed with this device.There were no patient complications reported as a result of this event.
Event or Problem Description
It was reported to boston scientific corporation that an advanix pancreatic stent was used during a stenting procedure in the pancreatic duct, performed on (b)(6) 2018.According to the complainant, during the procedure, when the physician attempted to deploy the stent in the pancreatic duct, it was noticed that the stent was deformed.The procedure was successfully completed with this device.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
A visual inspection of the returned device found that the advanix pancreatic delivery system has no visual defects, the returned device looks under good conditions without evidence of damages.The returned product was specifically inspected for kinked, detached or deformed sections and no defects of these were detected.A functional inspection performed and no resistance was felt and no issues were detected.Based on product analysis, it was revealed that the delivery system of an advanix pancreatic stent had no visual defects noted.The returned device looks under good conditions without evidence of damages.The returned product was specifically inspected for kinked, detached or deformed sections and no defects of these were detected; moreover, the guide catheter was fully retracted; no resistance was felt and no issues were detected.Additionally, the stent involved within the event was not present and was not returned for inspection, so no product analysis to this component could be performed.Therefore, no problem detected is selected as the most probable root cause for the complaint.Dhr review was performed and no anomalies were observed.

• 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: 7966560
• Report Number: 3005099803-2018-60828
• Device Sequence Number: 1434132
• 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
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/21/2018

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: 09/08/2019
• Device Model Number: M00535060
• Device Catalogue Number: 50317
• Device Lot Number: 0021847584
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/17/2018
• Initial Date Received by Manufacturer: 09/20/2018
• Supplement Date Received by Manufacturer: 10/30/2018
• Initial Report FDA Received Date: 10/15/2018
• Supplement Report FDA Received Date: 11/21/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1