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

Model Number	M00536540
Medical Device Problem Codes	Difficult or Delayed Positioning (1157); Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/21/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient's exact age is unknown; however it was reported that the patient was over the age of 18.(b)(4).According to the complainant, the suspect device has been disposed and is not available for return.If any further relevant information is received, 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 (ercp) procedure in the pancreatic duct performed on (b)(6) 2018.According to the complainant, during the procedure, when the advanix pancreatic stent was placed in the pancreatic duct, severe resistance was encountered when the stent was released.The device was deployed eventually, however the part of the stent was exposed to the papilla side of the pancreatic duct and when the stent was attempted to pull slightly, the stent kinked.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be good.

• 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: 7877687
• Report Number: 3005099803-2018-60444
• Device Sequence Number: 13972277
• 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
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/14/2018

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: 10/22/2019
• Device Model Number: M00536540
• Device Catalogue Number: 50309
• Device Lot Number: 22036146
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/21/2018
• Initial Report FDA Received Date: 09/14/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1