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

Model Number	M00539260
Medical Device Problem Codes	Break (1069); Positioning Failure (1158); Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/11/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation that a flexima biliary preloaded stent was to be implanted in the biliary tract to treat tight biliary stenosis during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2023.During the procedure, the stent could not be deployed inside the patient.The procedure was completed with another flexima biliary stent.There were no patient complications reported as a result of this event.Note: it was reported that the guidewire was inside the patient during the attempted deployment.However, the flexima biliary stent with delivery system instructions for use (ifu) states, "to deploy the stent, loosen the tuohy-borst adapter slightly and pull on the guide catheter luer-lok hub and guidewire.Hold the outer positioner stationary, while gently retracting the inner guide catheter and guidewire.Endoscopically monitor the stent position.Warning: if the guidewire is not completely retracted into the delivery system, the stent cannot be fully deployed." this event has been deemed an mdr-reportable event based on the investigation finding of the guide catheter break.Please see block h10 for the full investigation details.
Additional Manufacturer Narrative
Block e1: the initial reporter's facility name is second affiliated (b)(6).The initial reported address is (b)(6).Block h6: imdrf device code a0401 captures the reportable investigation finding of a guide catheter break.Block h10: the flexima biliary preloaded stent and delivery system were returned for analysis.Visual inspection found that the stent was still attached to the push catheter.One section of the guide catheter was detached, and the touhy borst was not returned.Visual and microscopic inspections found no damage to the suture hole.Functional analysis related to the deployment of the device was not performed due to the condition of the returned device.No other damages were noted with the stent or the delivery system.Product analysis confirmed the reported events of device user error and unsuccessful stent deployment.A labeling review was performed, and from the information available, this device was used in a manner inconsistent with the instructions for use (ifu)/product label.It was reported that the guidewire was inside the patient during the attempted deployment; however, the ifu cited: "to deploy the stent, loosen the tuohy-borst adapter slightly and pull on the guide catheter luer-lok hub and guidewire.Hold the outer positioner stationary, while gently retracting the inner guide catheter and guidewire.Endoscopically monitor the stent position.Warning: if the guidewire is not completely retracted into the delivery system, the stent cannot be fully deployed." thus, the user did not follow the manufacturer's instructions.Additionally, the reported event of unsuccessful stent deployment and the additional investigation finding of a guide catheter break were most likely due to procedural factors such as lesion characteristics, the handling of the device, and the technique used by the physician (force applied).Therefore, a review and analysis of all available information indicated that the most probable root cause of the reported event is adverse event related to procedure.

• Brand Name: FLEXIMA 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: 18809745
• Report Number: 3005099803-2024-00714
• Device Sequence Number: 7248787
• Product Code: FGE
• UDI-Device Identifier: 08714729162575
• UDI-Public: 08714729162575
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K965147
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/29/2024

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: 10/02/2025
• Device Model Number: M00539260
• Device Catalogue Number: 3926
• Device Lot Number: 0030266796
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/19/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/05/2024
• Initial Report FDA Received Date: 02/29/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/03/2022
• 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 Age: 50 YR
• Patient Sex: Male
• Patient Weight: 82 KG