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

Model Number	M00534710
Medical Device Problem Codes	Break (1069); Premature Activation (1484)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/24/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific that an advanix biliary stent device was used in the biliary duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure to treat biliary stenosis performed on (b)(6) 2023.During insertion, the stent deployed prematurely in the working channel of the scope in an uncontrolled manner.In order to recover the stent, the position had to be abandoned with 2 different wires (1 left and 1 right hepatic).The procedure was completed with another advanix biliary stent; however, the examination was significantly longer in an unstable patient.There were no patient complications reported as a result of this event, and the patient's condition at the conclusion of the procedure was reported to be good.This event has been deemed a reportable event based on the investigation results; proximal stent barb was slightly torn/stent broke.Please see block for full investigation details.
Additional Manufacturer Narrative
Imdrf device code a0401 captures for the reportable investigation results of stent barb torn.The returned advanix biliary stent was analyzed, and a visual evaluation noted that the suture was detached from the stent.The suture was not returned.A microscope inspection found that the proximal barb was slightly torn.No other problems with the device were noted.Taking all available information into consideration, most likely, the cause of the reported event was manipulation of the device during insertion through the scope.An activation of the stent may have been made without noticing it and this condition may have caused the torn proximal barb and detachment of the suture.Additionally, the pull wire was fully retracted, confirming that a deployment attempt was made to the device.Therefore, the most probable root cause is adverse event related to the procedure.

• 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: 16594984
• Report Number: 3005099803-2023-01400
• Device Sequence Number: 2893072
• Product Code: FGE
• UDI-Device Identifier: 08714729787266
• UDI-Public: 08714729787266
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• 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): 03/22/2023

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: 11/06/2024
• Device Model Number: M00534710
• Device Catalogue Number: 3471
• Device Lot Number: 0030491171
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/16/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/27/2023
• Initial Report FDA Received Date: 03/22/2023
• Date Device Manufactured: 11/07/2022
• 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
• Patient Age: 62 YR
• Patient Sex: Male