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

Model Number	M00534210
Medical Device Problem Codes	Break (1069); Premature Activation (1484); Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/05/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation that an advanix biliary stent was used during an endoscopic retrograde cholangiopancreatography procedure in the common bile duct, performed on (b)(6) 2022.During the procedure, there was difficulty advancing the stent into the biliary tree over the guidewire.The physician attempted to remove the stent from the patient to dilate the stricture prior to deployment.While the physician was trying to remove the full stent delivery system, the stent deployed in the working channel of the scope.Another advanix biliary stent was opened and successfully competed the procedure.There were no patient complications reported as a result of this event.Investigation results revealed the guide catheter detached/separated, therefore this event has been deemed an mdr reportable event.
Additional Manufacturer Narrative
(b)(4).The returned advanix rx biliary stent was analyzed, and a visual evaluation noted that the guide catheter was kinked and detached.Also, push catheter suture hole was torn and the suture thread was detached; suture detachment can lead to an unintended deployment of the stent.No other issues with the device were noted.The reported event was confirmed.Based on the provided and collected information, this device met all manufacturing requirements and no abnormalities were reported during the manufacturing process.After analysis it was determined that the guide catheter was kinked at the distal part and detached, suture thread was detached and push catheter suture hole was torn.The stent remained attached to the guide catheter with the suture still attached to it.It is most likely that procedural or anatomical factors encountered during the procedure could have contributed on the kink on guide catheter, as consequence the delivery system would have experienced difficulties on advancing through the anatomy.Probably, the stent got stuck in the working channel of the scope and attempts to retrieve the device from the scope and force applied to the device pulling it could have torn the suture hole and detached the guide catheter with the stent getting the components lodged in the scope.Once the suture hole is completely torn by the suture any backward movement of the delivery system can result in an unintended deployment.Therefore, adverse event related to procedure is selected as the most probable root cause for the complaint.A review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.

• 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: 14812532
• Report Number: 3005099803-2022-03329
• Device Sequence Number: 20067288
• Product Code: FGE
• UDI-Device Identifier: 08714729787303
• UDI-Public: 08714729787303
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 06/25/2022

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: 10/27/2023
• Device Model Number: M00534210
• Device Catalogue Number: 3421
• Device Lot Number: 0028282100
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/19/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/30/2022
• Initial Report FDA Received Date: 06/25/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/27/2021
• 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