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

Model Number	M00536670
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/26/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial reporter's state: (b)(6).(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 pancreatic duct stent placement procedure in the pancreatic duct, performed on (b)(6) 2020.According to the complainant, during the procedure, when the stent was tried to insert into the pancreatic duct, the guide catheter was able to pass through the stenosis part however, the stent was unable to cross the pancreatic duct.Due to this, the advanix pancreatic stent was flattened so it was removed from the patient.The procedure was successfully completed with a different pancreatic duct 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: 9848032
• Report Number: 3005099803-2020-01148
• Device Sequence Number: 2421186
• Product Code: FGE
• UDI-Device Identifier: 08714729857617
• UDI-Public: 08714729857617
• 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): 03/18/2020

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: 04/04/2021
• Device Model Number: M00536670
• Device Catalogue Number: 3667
• Device Lot Number: 0024555944
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/26/2020
• Initial Report FDA Received Date: 03/18/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1