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

Model Number	M00539270
Medical Device Problem Codes	Break (1069); Positioning Failure (1158); Use of Device Problem (1670); Defective Device (2588); Detachment of Device or Device Component (2907); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/23/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block a2: the patient's date of birth was on (b)(6) 1965.Block e1: initial reporter's address is no.(b)(6).Reported here as the address exceeded character limit for designated field.Block h6: imdrf device code a0401 captures the reportable investigation findings of catheter-guide break.Block h11: a flexima biliary preloaded stent was received for analysis.Visual inspection found that the guide catheter was kinked, buckled, and detached.The suture was not returned, and the push catheter suture hole was torn.A guidewire was found stuck inside the guide catheter.No other problems were noted with the device.Product analysis confirmed the reported event of stent failure to deploy.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 flexima biliary stent with delivery system instructions for use (ifu) states, "completely retract the guidewire into the endoscope.If the guidewire is not completely retracted into the delivery system, the stent cannot be fully deployed." additionally, it was reported that the barb flap cover was not used to insert the device through the biopsy cap.However, the ifu states, "slide the outer orange sleeve over the most proximal stent barb to hold it down for stent insertion." the investigation concluded that all the observed damages were due to excessive force being applied when it was felt that the stent was unable to deploy, potentially because the ifu was not followed or due to complications that could have occurred during the procedure.Therefore, a review and analysis of all available information indicated the most probable cause is of the reported event is failure to follow instructions.
Event or Problem Description
It was reported to boston scientific corporation that a flexima biliary preloaded stent was used to treat a bile duct stricture during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2024.During the procedure, the stent could not be deployed.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, "completely retract the guidewire into the endoscope.If the guidewire is not completely retracted into the delivery system, the stent cannot be fully deployed." additionally, it was reported that the barb flap cover was not used to insert the device through the biopsy cap.However, the ifu states, "slide the outer orange sleeve over the most proximal stent barb to hold it down for stent insertion." 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 detached.Please see block h11 for the 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: 21118440
• Report Number: 3005099803-2024-06875
• Device Sequence Number: 18008135
• Product Code: FGE
• UDI-Device Identifier: 08714729162582
• UDI-Public: 08714729162582
• 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): 01/09/2025

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 Model Number: M00539270
• Device Catalogue Number: M00539270
• Device Lot Number: 0032719690
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/15/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/16/2024
• Initial Report FDA Received Date: 01/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/25/2023
• 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: 59 YR
• Patient Sex: Male
• Patient Weight: 83 KG