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

Model Number	M00534680
Medical Device Problem Codes	Positioning Failure (1158); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/06/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The returned advanix biliary stent was analyzed, and a visual evaluation noted that the guide catheter was kinked.The stent was damaged.The suture thread was not returned.Microscope inspection revealed that the suture hole of the push catheter was torn.Functional inspection was performed and the pull wire was extended/retracted without issues.No other problems 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.Upon analysis, it was determined that the guide catheter was kinked.The stent was damaged.The suture thread was not returned.Microscope inspection revealed that the suture hole of the push catheter was torn, and functional inspection didn't show problems.The guide catheter kinked, stent damaged and suture hole of the push catheter torn indicates that the user may have experienced difficulties deploying the stent.The kinked guide catheter may be related to some technique applied by the user during procedure and or tortuous anatomy could have contributed on this problem.The stent could have been damaged by some interaction with another device and or some technique applied by the customer could have contributed as well.While those conditions were present and the user attempted to deploy the stent, this ended up tearing the suture hole of the push catheter.Review and analysis of all available information indicated that the root cause of the problems found is adverse event related to procedure since the adverse event occurred during the procedure and the device had no influence on event.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 an hemostasis procedure in the common bile duct on (b)(6) 2021.During the procedure, it was noted that stent would not disengage from the pusher.The procedure was successfully completed with another advanix biliary stent.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.Investigation results revealed that the stent was damaged, therefore this event has been deemed an mdr reportable event.

• 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: 12727395
• Report Number: 3005099803-2021-05515
• Device Sequence Number: 1558663
• Product Code: FGE
• UDI-Device Identifier: 08714729787235
• UDI-Public: 08714729787235
• 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): 11/01/2021

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: 05/28/2022
• Device Model Number: M00534680
• Device Catalogue Number: 3468
• Device Lot Number: 0025545470
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/23/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/06/2021
• Initial Report FDA Received Date: 11/01/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1