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

Model Number	M00533000
Medical Device Problem Codes	Device-Device Incompatibility (2919); Migration (4003)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/07/2024
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 impact code f9 captures the surgical intervention performed to remove the stent.Imdrf impact code f08 captures the patient's prolonged hospitalization.
Event or Problem Description
It was reported to boston scientific corporation that an advanix biliary double pigtail stent was implanted in the common bile duct to treat a pancreatic head mass stricture secondary to pancreatic cancer during a procedure performed on (b)(6) 2024.During a planned stent removal procedure on (b)(6) 2024, the advanix stent migrated proximally into the common bile duct, and a spybasket was used to retrieve it.The basket was able to go around the distal flange on the stent but was unable to pull it out of the duct.While the physician was pulling, the wires of the basket broke and wrapped around the elevator on the scope.The stent was stuck in the common bile duct, the basket became stuck on the stent, and the scope was stuck to the basket.The patient ended up being sent to surgery to have the stent removed and to cut the scope free from the stent.The patient was admitted to the hospital beyond the standard days of care; however, there were no patient complications reported as a result of this event.

• 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: 18992154
• Report Number: 3005099803-2024-01298
• Device Sequence Number: 18040040
• Product Code: FGE
• UDI-Device Identifier: 08714729786917
• UDI-Public: 08714729786917
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K101314
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• 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): 03/27/2024

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: M00533000
• Device Catalogue Number: 3300
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/07/2024
• Initial Report FDA Received Date: 03/28/2024
• 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