MAUDE Adverse Event Report: BOSTON SCIENTIFIC - SPENCER ADVANIX¿ PANCREATIC STENT KIT; CATHETER, BILIARY, DIAGNOSTIC

Model Number	M00537520
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Inflammation (1932); Pain (1994); Perforation (2001)
Date of Event	12/04/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The complainant indicated that the device remains implanted and will not be returned for evaluation; therefore, a failure analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental mdr will be filed.
Event or Problem Description
It was reported to boston scientific corporation that an advanix pancreatic stent kit was used during an endoscopic retrograde cholangiopancreatography (ercp) procedure in the pancreatic duct, performed on (b)(6) 2017.According to the complainant, a few hours after a pancreatic stent implantation, the patient experienced pain and inflammatory syndrome appeared.A ct scan was performed and showed a doudenal perforation at the tip of the pancreatic stent in the retroperitoneal position.Antibiotic therapy has been administered.Ovesco endoscopic clip type was used to a j3 ablation of the stent and closure of the incision.The patient's condition at the conclusion of the procedure was reported to be good.

• Brand Name: ADVANIX¿ PANCREATIC STENT KIT
• Common Device Name: CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): BOSTON SCIENTIFIC - SPENCER; 780 brookside drive; spencer IN 47460
• MDR Report Key: 7158009
• Report Number: 3005099803-2017-03845
• Device Sequence Number: 18867052
• Product Code: FGE
• UDI-Device Identifier: 08714729856290
• UDI-Public: 08714729856290
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K133700
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/07/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2018
• Device Model Number: M00537520
• Device Catalogue Number: 3752
• Device Lot Number: 20539950
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/07/2017
• Initial Report FDA Received Date: 01/02/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention