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

Model Number	M00534700
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/15/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(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 that an advanix rx biliary device was attempted to be used for a biliary stenting procedure on (b)(6) 2022.Upon opening the device package, the nurse found that the tip of the guide catheter was fractured.As a result, the device was not used.The procedure was successfully completed with another advanix rx biliary device.A photo of the complaint device was provided and showed that the tip of the guide catheter was fractured.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 as no patient complications.
Additional Manufacturer Narrative
Block h6: device code a0401 captures the reportable event of guide catheter fracture.Block h10: the returned advanix rx biliary device was analyzed, visual evaluation noted that the stent was loaded onto the delivery system and the locking mechanism was in a locked position.Additionally, a bent was found on the proximal section of the pull wire and the guide catheter tip was damaged.Activation of the device was performed, the guide catheter was retracted, and stent was deployed without issue.No other issues with the device were noted.The reported event was confirmed.According to the product analysis of the returned device, the guide catheter tip was damaged, and the pull wire was bent on the distal location.These device conditions could be due to handling and manipulation of the device while the user was removing the device from the tray or during preparation of the device for the procedure.Therefore, adverse event related to procedure was 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.A labeling review was performed and from the information available, this device was used per the directions for use (dfu) / product label.
Event or Problem Description
It was reported that a advanix rx biliary device was attempted to be used for biliary stenting procedure on (b)(6).Upon opening the device package, the nurse found that the tip of the guide catheter was fractured.As a result, the device was not used.The procedure was successfully completed with another advanix rx biliary device.A photo of the complaint device was provided and showed that the tip of the guide catheter was fractured.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 as no patient complications.

• 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: 15511502
• Report Number: 3005099803-2022-05664
• Device Sequence Number: 5920625
• Product Code: FGE
• UDI-Device Identifier: 08714729787259
• UDI-Public: 08714729787259
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/14/2022

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): Follow-Up
• Initial Date Received by Manufacturer: 09/19/2022
• Supplement Date Received by Manufacturer: 11/15/2022
• Initial Report FDA Received Date: 09/30/2022
• Supplement Report FDA Received Date: 12/15/2022
• 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