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

Model Number	M00534220
Medical Device Problem Codes	Positioning Failure (1158); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/13/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation that an advanix biliary and naviflex rx delivery system was to be used in the bile duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2024.During the procedure, the stent could not be deployed.The procedure was completed with a different stent.There were no patient complications reported as a result of this event.Note: this event has been deemed an mdr-reportable event based on the investigation finding of a stent barb torn.Please see block h10 for the full investigation details.
Additional Manufacturer Narrative
Imdrf device code a0414 captures the reportable investigation finding of a torn stent barb.: the advanix biliary stent and naviflex rx delivery system were received for analysis.Visual inspection found that the stent suture hole and stent bard were torn and the stent was still attached to the delivery system.No other damages were noted with the stent or the delivery system.Product analysis confirmed the reported event of stent failure to deploy because the device was returned with the stent still attached to the delivery system; and the stent suture hole and the stent barb were both torn.The investigation concluded that the stent barb could have gotten torn as a result of the way the device was handled during the procedure.It is also possible that the stent barb was damaged when the device was being taken out of the patient.There is no information regarding the usage of the stent barb cover, however, if the stent barb cover wasn't used during the procedure, the stent barb could have gotten torn while it was being placed into the scope.Additionally, if the stent barb was already torn when trying to deploy the stent, it would not have allowed stent deployment.A forced deployment would have only generated more pressure into the system; causing damage in the stent suture hole to the point of getting torn.Therefore, taking all available information into consideration, the overall root cause of the reported event is an adverse event related to the procedure.A product labeling review identified that the device was used per the instructions for use (ifu)/product label.

• 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: 19306957
• Report Number: 3005099803-2024-02241
• Device Sequence Number: 20663024
• Product Code: FGE
• UDI-Device Identifier: 08714729787310
• UDI-Public: 08714729787310
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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: Nurse
• Type of Report: Initial
• Report Date (Section B): 05/13/2024

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: 10/19/2024
• Device Model Number: M00534220
• Device Catalogue Number: 3422
• Device Lot Number: 0030387332
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/03/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/22/2024
• Initial Report FDA Received Date: 05/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/20/2022
• 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 Sex: Unknown