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

Model Number	M00539210
Medical Device Problem Codes	Break (1069); Positioning Failure (1158); Material Deformation (2976); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/29/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation that a flexima biliary stent was to be implanted in the common bile duct to treat cholelithiasis during an endoscopic retrograde cholangiopancreatography procedure (ercp) performed on (b)(6) 2025.The patient's anatomy was not tortuous.During the procedure, the gray guide catheter of the 7fr/7cm flexima stent broke off and the stent did not detach from the set.The procedure was completed with another of the same device there were no patient complications reported as a result of this event.Note: a review of the photo of the device provided showed that the pull wire was kinked.
Additional Manufacturer Narrative
Block h6: imdrf device code a0401 captures the reportable event of guide catheter break.
Additional Manufacturer Narrative
Blocks b5 and h6 (device code) were corrected following a review which identified that the complaint device does not have a pull wire.Block h6: imdrf device code a0401 captures the reportable event of guide catheter break.Block h11: a flexima biliary stent was received for analysis.Visual inspection found the guide catheter was detached and kinked, the push catheter was bent.Microscopic inspection was performed, and it was observed that the push catheter suture hole was torn.No other issues were noted with the stent and delivery system.Product analysis confirmed the reported events of catheter guide break, stent failure to deploy and catheter guide kinked.The observed problem of push catheter suture hole torn was most likely due to the physician's technique during the procedure.Taking all available information into consideration, the investigation concluded that the observed damages of guide catheter detached and kinked was likely caused by the force applied while the device was being pulled which led to the detachment of guide catheter and damaged push catheter.Therefore, the most probable cause of the reported event is adverse event related to procedure.A labeling review was performed and, from the information available, there is no information that this device was used in a manner inconsistent with the instructions for use (ifu)/ product label.
Event or Problem Description
It was reported to boston scientific corporation that a flexima biliary stent was to be implanted in the common bile duct to treat cholelithiasis during an endoscopic retrograde cholangiopancreatography procedure (ercp) performed on (b)(6) 2025.The patient's anatomy was not tortuous.During the procedure, the gray guide catheter of the 7fr/7cm flexima stent broke off and the stent did not detach from the set.The procedure was completed with another of the same device.There were no patient complications reported as a result of this event.Note: a review of the photo provided by the customer showed that the guide catheter was kinked.

• 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: arlene acevedo gutierrez ; 300 boston scientific way; marlborough, MA 01752 ; 7877968283
• MDR Report Key: 22081846
• Report Number: 3005099803-2025-02306
• Device Sequence Number: 12494138
• Product Code: FGE
• UDI-Device Identifier: 08714729162520
• UDI-Public: (01)08714729162520(17)260809(10)32189529
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/15/2025

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 Expiration Date: 08/09/2026
• Device Model Number: M00539210
• Device Catalogue Number: M00539210
• Device Lot Number: 0032189529
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/29/2025
• Supplement Date Received by Manufacturer: 06/23/2025
• Initial Report FDA Received Date: 05/23/2025
• Supplement Report FDA Received Date: 07/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/10/2023
• 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 Sex: Unknown