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

Model Number	M00537260
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/08/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).(b)(4).A visual evaluation of the advanix pancreatic stent was performed.It is was revealed that the pigtails section of the stent were found to be kinked, confirming the reported event.A manufacturing inspection was performed to assure that the devices met all the manufacturing specifications.Based on the product analysis, there is no control on how the units are handled in the field.Taking into consideration the returned device conditions and the information available, the failures found (stent bent/kink) is assigned as the most probable conclusion code classification of unintended use error caused or contributed to the event.This is defined as the interaction between the user and device, or sample, caused or contributed to the error.This includes the unintended inappropriate use of the device and incorrect sample preparation.Therefore the most probable root cause for this event is "unintended use error caused or contributed to event".A review of the device history record (dhr) was performed, no anomalies were found.
Event or Problem Description
It was reported to boston scientific corporation that an advanix pancreatic stent was used during a procedure, performed on (b)(6), 2019.According to the complainant, during the procedure, when they attempted to load the stent onto the naviflex7fr, it was difficult for them to set up or prepare.When replaced with another of the same delivery system, it mounted smoothly and the procedure was completed.There were no patient complications reported as a result of this event.This event has been deemed a reportable event based on the investigation results; pancreatic stent kinked.
Event or Problem Description
It was reported to boston scientific corporation that an advanix pancreatic stent was used during a procedure, performed on (b)(6) 2019.According to the complainant, during the procedure, when they attempted to load the stent onto the naviflex7fr, it was difficult for them to set up or prepare.When replaced with another of the same delivery system, it mounted smoothly and the procedure was completed.There were no patient complications reported as a result of this event.This event has been deemed a reportable event based on the investigation results; pancreatic stent kinked.
Additional Manufacturer Narrative
Initial reporter address: (b)(6).Problem code 2976 captures for the investigation results of pancreatic stent kinked.Updated product analysis: a visual evaluation of the advanix pancreatic stent was performed.It was revealed that the pigtails section of the stent were found to be kinked, confirming the reported event.The failure found (stent kinked in the distal pigtail) is an issue that could have been geerated by the manipulation of the device by the user and/or any force applied to the device.This device condition can affect the functionality of the device since this type of defects do not allow the device to perform its function as expected.There are manufacturing inspections in place to assure that the devices meet specifications such as final stent inspection, however, there is no control how the units are handled in the field therefore the most probable root cause for this event is "adverse event related to procedure".A review of the device history record (dhr) was performed, no anomalies were found.

• 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: 9202337
• Report Number: 3005099803-2019-04996
• Device Sequence Number: 19590809
• Product Code: FGE
• UDI-Device Identifier: 08714729856856
• UDI-Public: 08714729856856
• 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): 12/12/2019

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: 03/30/2020
• Device Model Number: M00537260
• Device Catalogue Number: 3726
• Device Lot Number: 0022734066
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/27/2019
• Initial Date Received by Manufacturer: 09/20/2019
• Supplement Date Received by Manufacturer: 11/19/2019
• Initial Report FDA Received Date: 10/17/2019
• Supplement Report FDA Received Date: 12/12/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1