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

Model Number	M00534240
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Codes	Abdominal Pain (1685); Perforation (2001)
Date of Event	02/01/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Block b3: approximated based on the date the manufacturer became aware of the event.Blocks d4, h4: the complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.Block e1: the reported healthcare facility is: (b)(6) hospital.Block h6: imdrf patient code e2114 captures the reportable event of perforation.Imdrf patient code e1002 captures the reportable event of abdominal pain.Imdrf device code a010402 captures the reportable event of stent migration.Imdrf impact code f08 captures the patient's admission to the emergency room.Imdrf impact code f2202 captures the endoscopic closure procedure performed to address the perforation.Imdrf impact code f2301 captures the use of an over the scope clip (otsc) to address the perforation and the use of forceps to remove the migrated stent.
Event or Problem Description
It was reported that an advanix biliary preloaded double bend stent was implanted in the bile duct to treat a tight proximal stricture during a stent placement procedure performed on an unknown date.The stent was successfully deployed during the procedure.Forty-eight hours post stent placement, the patient presented with a right upper quadrant pain and was admitted to the emergency room.Imaging showed that the stent had migrated distally out of the duct and perforated the duodenal wall.Subsequently, an endoscopic closure using an over the scope clip (otsc) was done to address the perforation.The stent was also removed with forceps and the procedure was completed.The patient's condition following the procedure was reported to be fully recovered.

• 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: 18803371
• Report Number: 3005099803-2024-00652
• Device Sequence Number: 7248129
• Product Code: FGE
• UDI-Device Identifier: 08714729787334
• UDI-Public: 08714729787334
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K101314
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/28/2024

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: M00534240
• Device Catalogue Number: 3424
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/02/2024
• Initial Report FDA Received Date: 02/28/2024
• 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; Hospitalization
• Patient Sex: Unknown