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

Model Number	M00536560
Medical Device Problem Codes	Positioning Failure (1158); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/24/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: imdrf device code a0406 captures the reportable event of pancreatic stent material deformation.
Event or Problem Description
It was reported to boston scientific that an advanix pancreatic stent was attempted to be placed during an endoscopic pancreatic stent placement procedure in the pancreatic duct performed on (b)(6) 2023.During the procedure, when the advanix pancreatic stent was loaded into the delivery system, the lumen of the stent felt flattened, hard and difficult to insert.The advanix pancreatic stent was able to advance into the target site for deployment, however, due to strong resistance, the stent could not be released.The procedure was completed with another advanix pancreatic stent.There were no patient complications or injury reported as a result of this event.
Event or Problem Description
It was reported to boston scientific that an advanix pancreatic stent was attempted to be placed during an endoscopic pancreatic stent placement procedure in the pancreatic duct performed on (b)(6) 2023.During the procedure, when the advanix pancreatic stent was loaded into the delivery system, the lumen of the stent felt flattened, hard and difficult to insert.The advanix pancreatic stent was able to advance into the target site for deployment, however, due to strong resistance, the stent could not be released.The procedure was completed with another advanix pancreatic stent.There were no patient complications or injury reported as a result of this event.
Additional Manufacturer Narrative
Block h6: imdrf device code a0406 captures the reportable event of pancreatic stent material deformation.The returned advanix pancreatic stent was analyzed, and a visual evaluation noted that the stent returned without any visible failure.Based on the microscopic inspection, there was no failure found either on the stent itself or in the stent lumen.No other problems with the device were noted.The reported event of stent material deformation could not be confirmed.Additionally, stent failure to deploy could not be confirmed since the delivery system was not returned, there was no evidence to clarify the reported allegation, consequently, classifying it as cause not established.Taking all available information into consideration, the investigation concluded that the most probable cause is no problem detected.

• Brand Name: ADVANIX PANCREATIC STENT
• Common Device Name: CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 780 brookside drive; spencer IN 47460
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 16957334
• Report Number: 3005099803-2023-02547
• Device Sequence Number: 19699525
• Product Code: FGE
• UDI-Device Identifier: 08714729857501
• UDI-Public: 08714729857501
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K133700
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/26/2023

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: 08/23/2023
• Device Model Number: M00536560
• Device Catalogue Number: 3656
• Device Lot Number: 0028931984
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 04/24/2023
• Supplement Date Received by Manufacturer: 06/08/2023
• Initial Report FDA Received Date: 05/18/2023
• Supplement Report FDA Received Date: 06/26/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/24/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown