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

Model Number	M00532260
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Perforation (2001)
Date of Event	09/18/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Block d4, h4: the complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.Block h6: imdrf device code a010402 captures the reportable event of stent migration.Imdrf patient code e2114 captures the reportable event of perforation.Imdrf impact code f23 captures the reportable event unexpected medical intervention.
Event or Problem Description
It was reported to boston scientific that an advanix biliary stent was implanted during a procedure in the duodenum.The procedure date is unknown.During an emergent follow-up on (b)(6) 2023, computed tomography (ct) scan was performed and it was found that the stent migrated, and one side of the pigtail perforated through the duodenum into the peritoneum.The perforated duodenum was closed using a boston scientific mantis clip device and the advanix biliary stent was retrieved using rat tooth forceps which successfully completed the procedure.There was no new stent implanted to replace the explanted advanix biliary stent.It was reported that the patient has experienced symptoms causing the emergent follow up.The patient's condition at the conclusion of the procedure was reported to be stable.

• Brand Name: ADVANIX BILIARY
• 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: 17932332
• Report Number: 3005099803-2023-05418
• Device Sequence Number: 15066647
• Product Code: FGE
• UDI-Device Identifier: 08714729787037
• UDI-Public: 08714729787037
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K101786
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/13/2023

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: M00532260
• Device Catalogue Number: 3226
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/20/2023
• Initial Report FDA Received Date: 10/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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