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

Model Number	M00539310
Medical Device Problem Codes	Activation, Positioning or Separation Problem (2906); Adverse Event Without Identified Device or Use Problem (2993); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/10/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation that a flexima biliary stent was implanted during a bile duct stent placement procedure performed on (b)(6) 2025.During the procedure, when the device was passed over the guidewire and reached the papilla, it had already been released.However, the suture thread remained on the stent.Additionally, the flap on the hilar side had been cut (it was not dislodged inside the patient).The procedure was completed with a different device.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block h6: imdrf device code a0414 captures the reportable event of stent barb torn material.
Additional Manufacturer Narrative
Block b5 has been updated with the additional information received on march 26, 2025.Block h6: imdrf device code a0414 captures the reportable event of stent barb torn material.Block h11: a flexima biliary stent was received for analysis.Visual and microscopic examination found the guide catheter was bent, the push catheter suture hole and stent bard were torn.No other damages were noted to the device.Product analysis the reported event of stent bard torn and suture deployment issue.The investigation concluded that these events may have occurred due to difficulties during stent deployment.If the device experienced pressure during deployment, possibly due to the physician's technique, the push catheter's suture hole could have torn from the pressure exerted by the suture, leading to deployment failure.Additionally, the catheter may have bent under the same pressure.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 stent was implanted during a bile duct stent placement procedure performed on (b)(6) 2025.During the procedure, when the device was passed over the guidewire and reached the papilla, it had already been released.However, the suture thread remained on the stent.Additionally, the flap on the hilar side had been cut (it was not dislodged inside the patient).The procedure was completed with a different device.There were no patient complications reported as a result of this event.Additional information received on march 26, 2020.The flexima biliary stent was placed to treat a stricture in the common bile duct.
Additional Manufacturer Narrative
Block h6: imdrf device code a0414 captures the reportable event of stent barb torn material.Block h11: a flexima biliary stent was received for analysis.Visual and microscopic examination found the guide catheter was bent, the push catheter suture hole and stent barb were torn.No other damages were noted to the device.Product analysis confirmed the suture deployment issue, as the push catheter's suture hole was torn.The reported event of a torn stent barb was also verified.It's possible that the barb was torn during the technique used when inserting the stent into the scope or while placing the device into the anatomy.This may have caused the stent to deploy early from the delivery system.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 stent was implanted during a bile duct stent placement procedure performed on (b)(6) 2025.During the procedure, when the device was passed over the guidewire and reached the papilla, it had already been released.However, the suture thread remained on the stent.Additionally, the flap on the hilar side had been cut (it was not dislodged inside the patient).The procedure was completed with a different device.There were no patient complications reported as a result of this event.Additional information received on march 26, 2020 the flexima biliary stent was placed to treat a stricture in the common bile duct.

• 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: 21520837
• Report Number: 3005099803-2025-00771
• Device Sequence Number: 15566967
• Product Code: FGE
• UDI-Device Identifier: 08714729162629
• UDI-Public: (01)08714729162629(17)270919(10)34885075
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 06/04/2025

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: M00539310
• Device Catalogue Number: M00539310
• Device Lot Number: 0034885075
• 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: 02/10/2025
• Supplement Date Received by Manufacturer: 03/26/2025; 05/09/2025
• Initial Report FDA Received Date: 03/04/2025
• Supplement Report FDA Received Date: 04/18/2025; 06/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/19/2024
• 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