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

Model Number	M00539220
Medical Device Problem Codes	Break (1069); Positioning Failure (1158); Stretched (1601); Use of Device Problem (1670); Activation, Positioning or Separation Problem (2906)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/18/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block e1: the initial reporter's facility name (b)(6) hospital.Block h6: imdrf device code a0401 captures the reportable investigation results of catheter-guide detached/separated.Block h10: a flexima biliary preloaded stent was received for analysis.The stent was received still attached to the delivery system.Visual inspection found the guide catheter separated into two pieces and the broken end was buckled; however, one of the pieces was not returned.Functional inspection was performed by manually pulling the stent and the stent was able to be deployed from the delivery system without any problems with the suture.Additionally, no signs of adhesive were found on the push catheter suture hole.No other problems were noted with the device.Product analysis confirmed the reported event of stent failure to deploy; however, the reported event of suture deployment issue was not confirmed.A product labeling review identified that the device was not used in accordance 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 states, "if the guidewire is not completely retracted into the delivery system, the stent cannot be fully deployed." the reported and observed events were likely due to operational factors such as the deployment technique of the stent.It is possible that an excess of force being applied during the retraction of the guide catheter may have caused friction between the push catheter and the guide catheter which then resulted to the guide catheter being stretched and detached.Therefore, a review and analysis of all available information indicated the most probable cause is adverse event related to procedure.
Event or Problem Description
It was reported to boston scientific corporation that a flexima biliary preloaded stent was used to treat a choledocholithiasis during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2024.During the procedure, the stent was unable to be deployed as the suture remained connected and was not released.The procedure was completed with another flexima biliary stent.There were no patient complications reported as a result of this event.The patient's condition following the procedure was reported to be stable.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, "if the guidewire is not completely retracted into the delivery system, the stent can not be fully deployed." the physician did not follow the steps cited in the ifu.This event has been deemed an mdr-reportable event based on the investigation results which revealed that the guide catheter was broken into two pieces.Please see block h10 for full investigation details.

• 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: 19214708
• Report Number: 3005099803-2024-01996
• Device Sequence Number: 8198809
• Product Code: FGE
• UDI-Device Identifier: 08714729162537
• UDI-Public: 08714729162537
• 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): 04/30/2024

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: 09/05/2025
• Device Model Number: M00539220
• Device Catalogue Number: 3922
• Device Lot Number: 0030092681
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/21/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/11/2024
• Initial Report FDA Received Date: 04/30/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/06/2022
• 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: 66 YR
• Patient Sex: Male
• Patient Weight: 70 KG