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); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/07/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: imdrf device code a0401 captures the reportable event of guide catheter break.
Event or Problem Description
It was reported to boston scientific corporation that a flexima biliary stents was implanted during procedure performed on (b)(6) 2025.During the procedure, the inner core was fractured, and the stent could not be deployed.Another flexima biliary stents was used to complete the procedure.There were no patient complications as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.Note: no further information has been obtained despite good faith efforts.
Additional Manufacturer Narrative
Block b5, e1, has been updated with the additional information received on may 25, 2025.Block h6: imdrf device code a0401 captures the reportable event of guide catheter break.Block h11: a flexima biliary stent and delivery system were returned for analysis without a part of the guide catheter.Visual examination of the returned device found the push catheter was kinked and bent, and the push catheter suture hole was torn.No other problems were noted to the stent and delivery system.The reported events of stent failure to deploy and catheter guide break were confirmed.Taking all available information into consideration, the investigation concluded that the reported event and observed damages were likely due to the physician not following the ifu during the procedure.It may be that not retracting the guidewire into the scope could have put more pressure to the handle, which caused the stent not to deploy correctly, which limited the performance of the device and contributed to the reported event and observed damages.Therefore, the most probable cause adverse event related to procedure.The labeling review found evidence to suggest that the device was used in a manner inconsistent with the labelled indications.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." however, it was reported that the guidewire was in the delivery system during the attempted deployment.The ifu contains detailed device information and instructions for the device use and there is no evidence that there is any issue with translation, wording, or graphics of the ifu/labeling information.
Event or Problem Description
It was reported to boston scientific corporation that a flexima biliary stents was implanted during procedure performed on (b)(6) 2025.During the procedure, the inner core was fractured, and the stent could not be deployed.Another flexima biliary stents was used to complete the procedure.There were no patient complications as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.Additional information received on may 25, 2025.It was reported to boston scientific corporation that a flexima biliary stents was to be implanted to treat a common bile duct stone in the duodenum during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2025.(b)(6) 2025 - fernc15.It was reported that the guidewire was in the delivery system 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.The physician did not follow the steps cited in the ifu.
Additional Manufacturer Narrative
Blocks a3a, a3b, b5, h6 (device codes) and h11 have been corrected.Block h6: imdrf device code a0401 captures the reportable event of guide catheter break.Block h11: a flexima biliary stent and delivery system were returned for analysis without a part of the guide catheter.Visual examination of the returned device found the push catheter was kinked and bent, and the push catheter suture hole was torn.No other problems were noted to the stent and delivery system.The reported events of stent failure to deploy and catheter guide break were confirmed based on the condition in which the device was returned.Taking all available information into consideration, the investigation concluded that the reported events and additional observed damages were most likely due to procedural factors as lesion characteristics, handling of the device, and the technique used by the physician (force applied).Therefore, the most probable cause of the events is adverse event related to procedure.
Event or Problem Description
It was reported to boston scientific corporation that a flexima biliary stents was to be implanted to treat a common bile duct stone in the duodenum during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2025.During the procedure, the inner core was fractured, and the stent could not be deployed.Another flexima biliary stents was used to complete the procedure.There were no patient complications as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.

• 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: 21829752
• Report Number: 3005099803-2025-01498
• Device Sequence Number: 9244656
• Product Code: FGE
• UDI-Device Identifier: 08714729162582
• UDI-Public: (01)08714729162582(17)261126(10)32933549
• 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,Followup,Followup
• Report Date (Section B): 07/18/2025

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: 0032933549
• 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: 03/24/2025
• Supplement Date Received by Manufacturer: 05/25/2025; 06/25/2025
• Initial Report FDA Received Date: 04/11/2025
• Supplement Report FDA Received Date: 06/12/2025; 07/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/27/2023
• 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: Male