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

Model Number M00534240

Device Problems Premature Activation (1484); Material Deformation (2976)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/18/2021

Event Type  malfunction  

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 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
• Type of Device: 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: 12494211
• MDR Text Key: 272108245
• Report Number: 3005099803-2021-04882
• Device Sequence Number: 1
• Product Code: FGE
• UDI-Device Identifier: 08714729787334
• UDI-Public: 08714729787334
• Combination Product (y/n): N
• Reporter Country Code: TW
• PMA/PMN Number: K101314
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 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
• Device Operator: 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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/25/2021
• Initial Date FDA Received: 09/20/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/12/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1