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

Model Number	M00545660
Medical Device Problem Codes	Break (1069); Nonstandard Device (1420); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/01/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block b3: date of event was approximated to february 01, 2026, as no event date was reported.Block h6: imdrf device code a0414 captures the reportable investigation finding of stent barb torn.Block h11: investigation results: based on the available information, boston scientific corporation confirmed the reported event of device damage/defective, the stent was returned with one of the stent barbs detached.The investigation concluded that the identified damage was most likely attributable to procedural factors, including handling of the device and the technique and force applied by physician during attempted insertion or deployment of the stent.Device history record review: it was confirmed this device met manufacturing specification prior to distribution and there were no manufacturing deviations which could have contributed to the reported event.Device technical analysis: a flexima rx biliary stent was returned for analysis.A visual examination of the returned device revealed that one of the stent barbs was detached.No other damages were noted to the stent or delivery system.Investigation conclusion: based on a thorough review of the reported complaint, boston scientific has assigned an investigation conclusion code of adverse event related to procedure.
Event or Problem Description
It was reported to boston scientific corporation that a flexima rx biliary stent was attempted to be implanted in the bile duct during a procedure performed on an unknown date.Reportedly, the stent had an unspecified damage.Thus, another flexima rx biliary stent was used to complete the procedure.There were no patient complicaitons as a result of this event.Note: this event has been deemed an mdr reportable event based on the investigation results which revealed that the stent barb was torn.Please see block h11 for full investigation details.
Event or Problem Description
It was reported to boston scientific corporation that a flexima rx biliary stent was attempted to be implanted in the bile duct during a procedure performed on an unknown date.Reportedly, the stent had an unspecified damage.Thus, another flexima rx biliary stent was used to complete the procedure.There were no patient complicaitons as a result of this event.Note: this event has been deemed an mdr reportable event based on the investigation results which revealed that the stent detached.Please see block h11 for full investigation details.
Additional Manufacturer Narrative
Block b5, h6 (device code) has been corrected.Block b3: date of event was approximated to february 01, 2026, as no event date was reported.Block h6: imdrf device code a0401 captures the reportable investigation finding of stent break.Block h11: investigation results: based on the available information, boston scientific corporation confirmed the reported event of device damage/defective, the stent was returned with one of the stent barbs detached.The investigation concluded that the identified damage was most likely attributable to procedural factors, including handling of the device and the technique and force applied by physician during attempted insertion or deployment of the stent.Device history record review: it was confirmed this device met manufacturing specification prior to distribution and there were no manufacturing deviations which could have contributed to the reported event.Device technical analysis: a flexima rx biliary stent was returned for analysis.A visual examination of the returned device revealed that one of the stent barbs was detached.No other damages were noted to the stent or delivery system.Investigation conclusion: based on a thorough review of the reported complaint, boston scientific has assigned an investigation conclusion code of adverse event related to procedure.

• Brand Name: RX 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: 25009178
• Report Number: 3005099803-2026-01530
• Device Sequence Number: 15987548
• Product Code: FGE
• UDI-Device Identifier: 08714729301837
• UDI-Public: (01)08714729301837(17)280711(10)36954008
• 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
• Report Date (Section B): 05/21/2026

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: M00545660
• Device Catalogue Number: M00545660
• Device Lot Number: 0036954008
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/03/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/30/2026
• Supplement Date Received by Manufacturer: 04/24/2026
• Initial Report FDA Received Date: 04/27/2026
• Supplement Report FDA Received Date: 05/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/12/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown