MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ADVANIX BILIARY; CATHETER, BILIARY, DIAGNOSTIC

Model Number	M00534360
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/18/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The returned advanix- navifles biliary stent was analyzed.A visual evaluation was noted that the stent was loaded in the delivery system when received.The stent was slightly bent and it presented some scratches, the stent bent could have caused some issues to advance the device through the scope, also scratched observed on the stent could have caused likely as a result of rubbing the stent when it was tried to be advanced.The outer diameter of the stent and the push catheter was measured and it was found within specifications.No other issues with the device were noted.The reported event was confirmed.Based on the product analysis, the issue occured during the procedure, it was determined that the stent was bent which could have cause some difficulty to advance the device to the intended location, also the stent presented some scratches that could have been caused as a result of rubbing the device against a hard surface or due to friction when it was advanced.As per complaint information the issue occurred during procedure, it is most likely that procedural or anatomical factors encountered during the procedure could have affected the overall performance of the device and its integrity.Therefore, adverse event related to procedure is selected as the most probable root cause for the complaint.A review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.A labeling review was performed and, from the information available, this device was used per the directions for use (dfu) / product label.
Event or Problem Description
This report is one of two complaints that pertain to the same event (mfr report # 3005099803-2020-02322, mfr.Report # 3005099803-2020-02327 and mfr.Report # ).It was reported to boston scientific corporation that an advanix-naviflex biliary stent was used during an endoscopic retrograde cholangiopancreatography (ercp) procedure in the common bile duct performed on (b)(6) 2020.According to the complainant, during the procedure, when the physician attempted to deploy the stent, the stent would not pass deep enough into the bile duct.Another advanix biliary stent was opened and successfully completed the procedure.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.This event has been deemed a reportable event based on the investigation results; stent damaged.

• Brand Name: ADVANIX BILIARY
• Common Device Name: CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 10361190
• Report Number: 3005099803-2020-03081
• Device Sequence Number: 19415788
• Product Code: FGE
• UDI-Device Identifier: 08714729787457
• UDI-Public: 08714729787457
• Combination Product (Y/N): N
• Initial Reporter Country: FI
• PMA/510(K) Number: K101314
• 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
• Report Date (Section B): 08/04/2020

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: 08/04/2021
• Device Model Number: M00534360
• Device Catalogue Number: 3436
• Device Lot Number: 0024212836
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/16/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/09/2020
• Initial Report FDA Received Date: 08/04/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1