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

Model Number	M00539260
Medical Device Problem Codes	Break (1069); Positioning Failure (1158); Premature Activation (1484); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/24/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block e1: the initial reporter's address 2 is (b)(6) - reported here as it exceeded the maximum character limit for the designated field.Block h6: imdrf device code a0401 captures the reportable investigation result of catheter guide break.Block h11: a flexima biliary stent with delivery system was returned for analysis.Visual inspection noticed the guide catheter kinked and detached, the push catheter kinked, and the push catheter suture hole torn.Additionally, a guidewire was found stuck within the guide catheter.The suture did not return.No other damages were noted to the device.Product analysis confirmed the reported event of stent failure to deploy.The investigation concluded that the reported event and the observed problems were likely due to anatomical or procedural factors encountered during the procedure.It may be that lesion characteristics, handling of the device and the technique used by the physician (force applied), limited the performance of the device and contributed to the observed problems.Therefore, a review and analysis of all available information indicate 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 to be implanted to treat gallstones in the bile duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2024.During the procedure, after the stones were removed, the stent was placed but great resistance was felt, and the stent could not be deployed successfully.The device was then withdrawn, but it was noticed that the stet fell off.The procedure was completed with another of the same device.There was no patient complication reported as a result of this event and the patient's condition was stable.Note: 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 full investigation details.
Additional Manufacturer Narrative
Block e1: the initial reporter's address 2 is (b)(6).Block h6: imdrf device code a0401 captures the reportable investigation result of catheter guide break.Block h11: a flexima biliary stent with delivery system was returned for analysis.Visual inspection noticed the guide catheter kinked and detached, the push catheter kinked, and the push catheter suture hole torn.Additionally, a guidewire was found stuck within the guide catheter.The suture did not return.No other damages were noted to the device.Product analysis confirmed the reported event of stent failure to deploy.The reported event of stent premature deployment was not confirmed.The investigation concluded that the reported events and the observed problems were likely due to anatomical or procedural factors encountered during the procedure.It may be that anatomical conditions and/or the technique used by the physician, limited the performance of the device and contributed to the observed problems.Therefore, a review and analysis of all available information indicate 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 to be implanted to treat gallstones in the bile duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2024.During the procedure, after the stones were removed, the stent was placed but great resistance was felt, and the stent could not be deployed successfully.The device was then withdrawn, but it was noticed that the stet fell off.The procedure was completed with another of the same device.There was no patient complication reported as a result of this event and the patient's condition was stable.Note: 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 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: arlene acevedo gutierrez ; 300 boston scientific way; marlborough, MA 01752 ; 7877968283
• MDR Report Key: 21809753
• Report Number: 3005099803-2025-01443
• Device Sequence Number: 7408707
• Product Code: FGE
• UDI-Device Identifier: 08714729162575
• UDI-Public: (01)08714729162575(17)260529(10)31715894
• 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
• Report Date (Section B): 05/12/2025

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: 05/29/2026
• Device Model Number: M00539260
• Device Catalogue Number: M00539260
• Device Lot Number: 0031715894
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/12/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/17/2025
• Supplement Date Received by Manufacturer: 04/14/2025
• Initial Report FDA Received Date: 04/09/2025
• Supplement Report FDA Received Date: 05/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/30/2023
• 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: 56 KG