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

Model Number	M00537390
Medical Device Problem Codes	Difficult or Delayed Positioning (1157); Use of Device Problem (1670)
Health Effect - Clinical Code	Perforation (2001)
Date of Event	10/11/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported to boston scientific corporation that an advanix pancreatic stent was used during a pancreatic duct stent placement procedure in the pancreatic duct, performed on (b)(6) 2021.During the procedure, when the physician advanced the stent through the guidewire and when it was pulled out firmly and forcefully, the guidewire may have bounce back and perforated and the pancreatic duct stent was also advanced through the guide wire and became perforated.A perforation of the pancreatic duct occurred while the device was in place.The procedure was completed in an emergency surgery to treat the perforation and a pancreaticoduodenectomy was performed.After that procedure the patient condition was stable and the patient was discharged.
Additional Manufacturer Narrative
Initial reporter address: (b)(6).(b)(4).The complainant indicated that the device was disposed 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 medwatch will be filed.

• Brand Name: ADVANIX PANCREATIC STENT KIT
• 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: 12776824
• Report Number: 3005099803-2021-05678
• Device Sequence Number: 6025776
• Product Code: FGE
• UDI-Device Identifier: 08714729856382
• UDI-Public: 08714729856382
• 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
• Report Date (Section B): 11/09/2021

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: 06/06/2022
• Device Model Number: M00537390
• Device Catalogue Number: 3739
• Device Lot Number: 0026534792
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/12/2021
• Initial Report FDA Received Date: 11/09/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/08/2020
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown