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

Model Number	M00539260
Medical Device Problem Codes	Break (1069); Positioning Failure (1158); Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/17/2025
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 biliary tract for biliary dilation during a biliary stent placement procedure performed on (b)(6) 2025.The patient's anatomy was severely tortuous.During the procedure, the pull wire broke and the flexima stent was unable to be deployed.The procedure was completed using another of the same device.There were no patient complications reported as a result of this event and the patient condition after the procedure was reported to be stable.Note: it was reported that the barb flap cover was not used to insert the device through the biopsy cap.However, the flexima biliary stent with delivery system instructions for use (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.
Additional Manufacturer Narrative
Block h6: imdrf device code a0401 captures the reportable event of pull wire break.
Event or Problem Description
It was reported to boston scientific corporation that a flexima biliary stent was to be implanted in the biliary tract for biliary dilation during a biliary stent placement procedure performed on (b)(6) 2025.The patient's anatomy was severely tortuous.During the procedure, the pull wire broke and the flexima stent was unable to be deployed.The procedure was completed using another of the same device.There were no patient complications reported as a result of this event and the patient condition after the procedure was reported to be stable.Note: it was reported that the barb flap cover was not used to insert the device through the biopsy cap.However, the flexima biliary stent with delivery system instructions for use (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.
Additional Manufacturer Narrative
Block h6: imdrf device code a0401 captures the reportable event of pull wire break.Block h11: a flexima biliary stent was received for analysis; only the stent was received.Visual examination of the returned device found no damages to the stent.Product analysis did not confirm the reported events of pull wire break and stent failure to deploy.However, the reported event of device use of device issue - user error was confirmed.Taking all available information into consideration, the investigation concluded that there is not enough evidence to establish the cause the reported events of pull wire break and stent failure to deploy without proper evaluation of the device.The investigation findings do not lead to a clear conclusion about the cause of the reported event; therefore, the most probable cause was unable to be established.A product labeling review identified that the device was used in a manner inconsistent with the ifu (instructions for use) / product label.The complainant reported that the stent barb cover was not used to insert the device through the biopsy cap as the ifu states "slide the outer orange sleeve over the most proximal stent barb to hold it down for stent insertion.".
Event or Problem Description
It was reported to boston scientific corporation that a flexima biliary stent was to be implanted in the biliary tract for biliary dilation during a biliary stent placement procedure performed on (b)(6) 2025.The patient's anatomy was severely tortuous.During the procedure, the pull wire broke and the flexima stent was unable to be deployed.The procedure was completed using another of the same device.There were no patient complications reported as a result of this event and the patient condition after the procedure was reported to be stable.Note: it was reported that the barb flap cover was not used to insert the device through the biopsy cap.However, the flexima biliary stent with delivery system instructions for use (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.
Additional Manufacturer Narrative
Block h6 (imdrf device code) was corrected.Block h6: imdrf device code a0401 captures the reportable event of guide catheter break.Block h11: investigation results: based on the available information, boston scientific could not confirm the reported events of catheter guide break and stent failure to deploy, only the stent was returned for analysis and no damage was identified.It was reported that the barb flap cover was not used to insert the device through the biopsy cap.However, the flexima biliary stent with delivery system instructions for use (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.Without proper evaluation of the device, it is unknown if the reported events were due to the technique used during the procedure, anatomical conditions or related to device malfunction.Device history record: it was confirmed this device met manufacturing specifications prior to distribution and there were no manufacturing deviations which could have contributed to the reported event.Device technical analysis: a flexima biliary stent was received for analysis; the delivery system was not returned.Visual examination of the stent found no damages.Labeling review: 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.Risk review: a risk review was completed and confirmed that the event of catheter guide break was defined in the risk documentation.This event type has been accounted for during product risk analysis to support acceptable risk benefit for the product.Investigation conclusion: based on a thorough review of the reported complaint, boston scientific has assigned an investigation conclusion code of cause not established.

• 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: christina lam ; 300 boston scientific way; marlborough, MA 01752 ; 9145716918
• MDR Report Key: 21425848
• Report Number: 3005099803-2025-00604
• Device Sequence Number: 7937163
• Product Code: FGE
• UDI-Device Identifier: 08714729162575
• UDI-Public: (01)08714729162575(17)270430(10)33933290
• 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): 04/27/2026

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: M00539260
• Device Catalogue Number: M00539260
• Device Lot Number: 0033933290
• 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: 02/09/2025
• Supplement Date Received by Manufacturer: 03/19/2025; 03/30/2026
• Initial Report FDA Received Date: 02/20/2025
• Supplement Report FDA Received Date: 04/09/2025; 04/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/30/2024
• 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 Age: 63 YR
• Patient Sex: Male
• Patient Weight: 60 KG