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

Model Number	M00536540
Medical Device Problem Codes	Entrapment of Device (1212); Premature Activation (1484); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/31/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block e1: initial reporter facility name: (b)(6) university of medicine initial reporter city: (b)(6) 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 used during an endoscopic pancreatic stent placement procedure, performed on (b)(6) 2022.During the procedure, outside the patient, when the device was being inserted into the endoscope, it became stuck and was difficult to push through.It was noted that the device was detached and remained inside the scope.The device was removed from the forceps port but could not be used due to damage as the device had become flattened.There were no patient complications reported as a result of this event.The patient's condition was reported to be as no patient injury.
Event or Problem Description
It was reported to boston scientific that an advanix pancreatic stent was attempted to be used during an endoscopic pancreatic stent placement procedure, performed on (b)(6)2022.During the procedure, outside the patient, when the device was being inserted into the endoscope, it became stuck and was difficult to push through.It was noted that the device was detached and remained inside the scope.The device was removed from the forceps port but could not be used due to damage as the device had become flattened.There were no patient complications reported as a result of this event.The patient's condition was reported to be as no patient injury.
Additional Manufacturer Narrative
Correction to block d4: updated upn number block e1: initial reporter facility name: north medical center kyoto prefectural university of medicine initial reporter city: yoza district, kyoto prefecture block h6: imdrf device code a0406 captures the reportable event of pancreatic stent material deformation.Block h10: the returned advanix pancreatic stent was analyzed, and a visual evaluation noted that one side of the stent was jammed and damaged.No other problems with the device were noted.The reported event of stent material deformation and device entrapment was confirmed.However, the reported event of stent premature deployment was not confirmed.A review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.Taking all available information into consideration, most likely, the cause of the problem was due to incorrect positioning of the stent when it was inserted into the scope and manipulation of the device during insertion through the scope.Therefore, the most probable cause is adverse event related to the procedure.

• 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: 17201179
• Report Number: 3005099803-2023-03344
• Device Sequence Number: 6591951
• Product Code: FGE
• UDI-Device Identifier: 08714729857488
• UDI-Public: 08714729857488
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/09/2023

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: 08/09/2023
• Device Model Number: M00536540
• Device Catalogue Number: 3654
• Device Lot Number: 0028845924
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/06/2023
• Supplement Date Received by Manufacturer: 07/20/2023
• Initial Report FDA Received Date: 06/26/2023
• Supplement Report FDA Received Date: 08/09/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/10/2022
• 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