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

Model Number	M00533350
Medical Device Problem Codes	Contamination (1120); Tear, Rip or Hole in Device Packaging (2385)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/01/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block b3: approximated based on the date the manufacturer became aware of the event.Block h6: imdrf device code a1801 captures the reportable event of device contamination.
Event or Problem Description
It was reported to boston scientific corporation that an advanix-naviflex biliary stent was to be used during a procedure performed on an unknown date.During preparation, it was noted that the device packaging was ripped/ torn.The stent is no longer sterile and could not be used anymore.Another advanix-naviflex biliary stent was used to complete the procedure.There were no patient complications reported as a result of this event.
Event or Problem Description
It was reported to boston scientific corporation that an advanix-naviflex biliary stent was to be used during a procedure performed on an unknown date.During preparation, it was noted that the device packaging was ripped/ torn.The stent is no longer sterile and could not be used anymore.Another advanix-naviflex biliary stent was used to complete the procedure.There were no patient complications reported as a result of this event.Additional information received on august 7, 2024.It was reported that there is an air cushion on the top of the products inside the packaging which prevents damage when opening.Furthermore, no damage has been observed on the outer packaging.
Additional Manufacturer Narrative
Block b5 has been updated with the additional information received on august 7, 2024.Block b3: approximated based on the date the manufacturer became aware of the event.Block h6: imdrf device code a1801 captures the reportable event of device contamination.

• 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: 19865461
• Report Number: 3005099803-2024-03624
• Device Sequence Number: 18182587
• Product Code: FGE
• UDI-Device Identifier: 08714729786726
• UDI-Public: 08714729786726
• Combination Product (Y/N): N
• Initial Reporter Country: RS
• 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,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/04/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/06/2026
• Device Model Number: M00533350
• Device Catalogue Number: 3335
• Device Lot Number: 0033572095
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/01/2024
• Supplement Date Received by Manufacturer: 08/07/2024
• Initial Report FDA Received Date: 07/30/2024
• Supplement Report FDA Received Date: 09/04/2024
• Date Device Manufactured: 03/06/2024
• 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
• Patient Sex: Unknown