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

Model Number	M00537290
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/07/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The returned advanix pancreatic stent was analyzed, and a visual evaluation noted that the stent was bent in the middle and the pigtail was kinked.A functional evaluation noted that the findings from visual assessment indicate that likely there were issues advancing the device.No other issues with the device were noted.The reported event was confirmed.The issue occurred during procedure and the patient presented stricture, it is most likely that procedural or anatomical factors encountered during procedure could have affected the device performance and its integrity.Patient anatomy can cause issues to advance the device to the intended location, force applied to the device in order to advance it and customer maneuvering during placement can lead to bend/kink the stent, this condition could have affected the overall performance of the device.Therefore, "adverse event related to patient condition" 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.
Event or Problem Description
It was reported to boston scientific corporation that an advanix pancreatic stent was used during an endoscopic retrograde cholangiopancreatography procedure in the common bile duct, performed on (b)(6) 2020.According to the complainant, during the procedure, inside the patient, when the physician attempted to deploy the stent, the stent could not pass through the stricture site of the anatomy.Another advanix pancreatic 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 stable.This event has been deemed a reportable event based on the investigation finding of pancreatic stent bent/kinked.

• Brand Name: ADVANIX PANCREATIC STENT
• Common Device Name: CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 10000784
• Report Number: 3005099803-2020-01761
• Device Sequence Number: 19622543
• Product Code: FGE
• UDI-Device Identifier: 08714729856887
• UDI-Public: 08714729856887
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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
• Report Date (Section B): 04/27/2020

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: 12/22/2020
• Device Model Number: M00537290
• Device Catalogue Number: 3729
• Device Lot Number: 0024014290
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/03/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/01/2020
• Initial Report FDA Received Date: 04/27/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 53 YR