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

Model Number	M00534280
Medical Device Problem Codes	Break (1069); Defective Device (2588)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/13/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Adverse event problem: imdrf device code a0401 captures the reportable event of stent broken; imdrf device code a0203 captures the reportable event of stent damaged; imdrf impact code f23 captures the reportable event of unexpected medical intervention; imdrf impact code f2301 captures the reportable event of additional device required.
Event or Problem Description
It was reported to boston scientific that an advanix biliary stent was attempted to be used during an endoscopic retrograde cholangiopancreatography (ercp) procedure to treat biliary stenosis on a pancreatic tumor performed on (b)(6) 2023.During the procedure, after placing one 8.5 french plastic stent successfully (stent manufacturer unknown) a second stent, an advanix biliary stent was attempted to be place, however, it was impossible to pass the guidewire into the tight stenosis.It was decided to remove the advantix biliary stent and insert a metal stent.During the removal, using rat tooth forceps, the inner pin of the advanix biliary stent become stuck in the tumor and the stent was torn.The procedure was successfully completed with a new advanix biliary stent.There were no known patient complications reported.

• 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: 16708127
• Report Number: 3005099803-2023-01712
• Device Sequence Number: 14348783
• Product Code: FGE
• UDI-Device Identifier: 08714729787372
• UDI-Public: 08714729787372
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/10/2023

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 Expiration Date: 03/21/2024
• Device Model Number: M00534280
• Device Catalogue Number: 3428
• Device Lot Number: 0029084939
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/17/2023
• Initial Report FDA Received Date: 04/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/22/2022
• 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