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

Model Number	M00534240
Medical Device Problem Codes	Premature Activation (1484); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/18/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient's exact age is unknown; however it was reported that the patient was over the age of 18.(b)(4).The returned advanix-naviflex biliary stent was analyzed, and a visual evaluation noted that the stent was returned attached to the push catheter by the suture thread.It was observed that the stent was damaged and kinked, the push catheter presented several kinks.A functional evaluation noted that the pull wire presented difficulties to extend/retract the guide catheter.No other issues with the device were noted.The reported event was confirmed.According to the product analysis, the stent returned attached to the push catheter by the suture thread, therefore no problem detected was selected for the report of stent premature deployment.The kinks on the push catheter may be related to some user manipulation, some technique applied during procedure and/or tortuous anatomy, once the push catheter was kinked the user may have experimented some difficulties while extending/retracting the guide catheter, this condition could have contributed on the kink and damages on the stent while trying to deploy it.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.
Event or Problem Description
It was reported to boston scientific corporation that an advanix biliary stent was used during a common bile duct stricture procedure in the common bile duct, performed on (b)(6) 2021.During the procedure and outside the patient, when the physician attempted to use the stent, it was noticed that the stent deployed prematurely to the wrong position.Another advanix biliary stent was opened and successfully completed the procedure.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.This event has been deemed a reportable event based on the investigation finding of stent damaged.

• Brand Name: ADVANIX BILIARY
• Common Device Name: CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 12494211
• Report Number: 3005099803-2021-04882
• Device Sequence Number: 17090812
• Product Code: FGE
• UDI-Device Identifier: 08714729787334
• UDI-Public: 08714729787334
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• 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: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/20/2021

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: 02/12/2023
• Device Model Number: M00534240
• Device Catalogue Number: 3424
• Device Lot Number: 0026803868
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/11/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/25/2021
• Initial Report FDA Received Date: 09/20/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1