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

Model Number	M00537280
Medical Device Problem Codes	Break (1069); Material Deformation (2976)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/13/2019
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 an endoscopic retrograde cholangiopancreatography with pancreatic stent implantation performed in the pancreatic duct on (b)(6) 2019.According to the complainant, during the procedure, the stent kinked on the push catheter, although it had been moistened.The stent was pierced at the site of the bend, making it unusable.The procedure was successfully completed with another advanix biliary stent.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block f10: problem code 2976 captures for the reportable event of stent kinked.Problem code 1069 captures for the reportable event of stent broken.Block h10: product analysis a visual evaluation of the returned advanix pancreatic stent was performed.The stent was kinked at pigtail section, also it was punctured in the same location where it was kinked as mentioned in the event description "the stent was pierced at the site of the bend"; consequently, confirming the reported complaint.Based on the product analysis, it is most likely that procedural or anatomical factors encountered during procedure could have affected the device performance and its integrity.Handling and manipulation of the device during its use could have kinked the stent, interaction with the guidewire and delivery system could have contributed with the kink observed, also interaction with the guidewire when the stent is being loaded can result in stent punctured at pigtail section.Therefore the most probable root cause for this event is "adverse event related to procedure" since the adverse event occurred during the procedure and the device had no influence on 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 an endoscopic retrograde cholangiopancreatography with pancreatic stent implantation performed in the pancreatic duct on (b)(6) 2019.According to the complainant, during the procedure, the stent kinked on the push catheter, although it had been moistened.The stent was pierced at the site of the bend, making it unusable.The procedure was successfully completed with another advanix biliary stent.There were no patient complications reported as a result of this event.

• 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: 9419040
• Report Number: 3005099803-2019-05968
• Device Sequence Number: 2423917
• Product Code: FGE
• UDI-Device Identifier: 08714729856870
• UDI-Public: 08714729856870
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/10/2020

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: 12/16/2020
• Device Model Number: M00537280
• Device Catalogue Number: 3728
• Device Lot Number: 0023985528
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/18/2019
• Initial Date Received by Manufacturer: 11/13/2019
• Supplement Date Received by Manufacturer: 01/15/2020
• Initial Report FDA Received Date: 12/05/2019
• Supplement Report FDA Received Date: 02/10/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1