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

Model Number	M00534700
Medical Device Problem Codes	Break (1069); Positioning Failure (1158)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/17/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.(b)(4).The device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.
Event or Problem Description
It was reported to boston scientific corporation that an advanix-naviflex biliary stent was used during an endoscopic retrograde cholangiopancreatography procedure in the bile duct, performed on (b)(6) 2022.During the procedure, when the physician attempted to deploy the stent, the guide catheter remained inside the stent preventing the stent to be deployed.It was noticed that the stent broke inside the guide catheter.The broken stent was removed within the delivery system and the procedure was successfully completed with another advanix-naviflex biliary stent.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block h6: medical device problem code a0401 captures the reportable event of guide catheter break.Block h10: the returned advanix-naviflex biliary stent was analyzed, and a visual evaluation noted that the pull wire was kinked, the push catheter was kinked, the device was returned with the pull wire cap detached, the push catheter was torn and detached.The returned stent did not present any problem.No other issues with the device were noted.The reported event of stent break was not confirmed.According to the product analysis, it is determined that the stent does not have any problem and will be coded as no problem detected.The manipulation of the user, some technique performed during the procedure and / or even anatomical factors found during the procedure could have contributed to the push catheter was kinked, as a consequence, the pull wire was kinked, once the push catheter was kinked, the user may have experienced difficulties while retracting/extending the pull wire, which led the user to apply additional force/tension, as a consequence the push catheter was detached, the pull wire cap was detached.Therefore, adverse event related to procedure is selected as the most probable root cause for the complaint.
Event or Problem Description
It was reported to boston scientific corporation that an advanix-naviflex biliary stent was used during a procedure performed on (b)(6) 2022.During the procedure, when the physician attempted to deploy the stent, the guide catheter remained inside the stent preventing the stent to be deployed.It was noticed that the stent broke inside the patient.The broken stent was removed within the delivery system and the procedure was successfully completed with another advanix-naviflex biliary stent.There were no patient complications reported as a result of this event.

• 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: 14740038
• Report Number: 3005099803-2022-03221
• Device Sequence Number: 2215185
• Product Code: FGE
• UDI-Device Identifier: 08714729787259
• UDI-Public: 08714729787259
• 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: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 09/26/2022

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: 11/08/2023
• Device Model Number: M00534700
• Device Catalogue Number: 3470
• Device Lot Number: 0028348586
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/24/2022
• Supplement Date Received by Manufacturer: 09/01/2022
• Initial Report FDA Received Date: 06/18/2022
• Supplement Report FDA Received Date: 09/26/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/08/2021
• 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