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

Model Number	M00537460
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/01/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: approximated based on the date the manufacturer became aware of the event.(b)(6).(b)(4).The returned advanix pancreatic stent kit was analyze, and a visual evaluation noted that the naviflex rx pusher returned in its sealed pouch.The advanix pancreatic stent was returned out of its pouch and it was kinked at proximal section.No other issues with the device were noted.The reported event was confirmed.Based on the product analysis, it is most likely that handling and manipulation of the device during prepping/unpacking/ could have contributed with the reported event, also advancing the device over the guide wire could have kinked the stent.During manufacturing, it was confirmed the part has measured correctly and taken the correct data points by looking at the screen and confirming all points were taken on the stent: at the start of a barb cut, at the end of the stent, at the ro marker, and along the tip taper.This step of the process would have detected the observed damage on the stent.Therefore the most probable root cause for this event is adverse event related to procedure and the device had no influence on event.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 kit was opened to be used for pancreatic duct stent insertion.The exact event date was not provided.According to the complainant, during preparation,, when unpacking the device, it was found that the stent body was crushed.The procedure was successfully completed with another advanix pancreatic stent.There were no patient complications reported as a result of this event.

• Brand Name: ADVANIX PANCREATIC STENT KIT
• Common Device Name: CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 10733195
• Report Number: 3005099803-2020-04910
• Device Sequence Number: 1114163
• Product Code: FGE
• UDI-Device Identifier: 08714729856245
• UDI-Public: 08714729856245
• 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
• Report Date (Section B): 10/26/2020

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: 12/26/2021
• Device Model Number: M00537460
• Device Catalogue Number: 3746
• Device Lot Number: 0025660857
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/14/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/30/2020
• Initial Report FDA Received Date: 10/26/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1