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

Model Number	M00532210
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/02/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event was approximated to (b)(6) 2021 based on the date the manufacturer became aware of the event.(b)(4).The returned advanix-naviflex biliary stent was analyzed, and a visual evaluation noted that the stent presented part of guide catheter loaded.The stent was damaged and one pigtail was deformed.No specific failure was reported against the device therefore no assessment on the confirmation of the complaint can be made.No other issues with the device were noted.Based on the product analysis, the device met all manufacturing requirements and no abnormalities were reported during the manufacturing process.After analysis it was determined that the stent returned with part of the guide catheter loaded, the stent was severely damaged and one pigtail shape was deformed.The stent damaged and the pigtail shape deformed may be related to some user manipulation while setting up the stent on the delivery system and/or some technique applied during procedure while trying to deploy the stent.Therefore, adverse event related to procedure is selected as the most probable root cause for this 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
An advanix biliary stent was returned to boston scientific corporation.This product was returned to the manufacturer without any report of performance issues or adverse patient effects.This event has been deemed reportable based on the investigation results; stent damaged.Please see full investigation details.

• 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: 12604646
• Report Number: 3005099803-2021-05166
• Device Sequence Number: 11080431
• Product Code: FGE
• UDI-Device Identifier: 08714729786993
• UDI-Public: 08714729786993
• Combination Product (Y/N): N
• PMA/510(K) Number: K101786
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/11/2021

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: 06/29/2022
• Device Model Number: M00532210
• Device Catalogue Number: 3221
• Device Lot Number: 0025650532
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/02/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/14/2021
• Initial Report FDA Received Date: 10/11/2021
• Patient Sequence Number: 1