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

Model Number	M00540110
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/06/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation that a flexima nasobiliary catheter was to be implanted during a procedure performed on (b)(6) 2025.Prior to the procedure, it was noticed that near the pig part and the hardness change section was separated, rendering it unusable.Another flexima nasobiliary catheter was used to complete the procedure.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block h6: imdrf device code a0501 captures the reportable event of pigtail detachment of device or device component.
Additional Manufacturer Narrative
Block h6: imdrf device code a0501 captures the reportable event of pigtail detachment of device or device component.Block h11: a flexima nasobiliary catheter was returned for analysis.Visual and microscopic inspection revealed that the pigtail part end of the catheter was detached.No other damages were noted.Product analysis confirmed the reported event of pigtail detachment of device or device component since the pigtail part end of the catheter was detached.A review of the device manufacturing records confirmed that the device was accurately assembled.The investigation concluded that the reported event was most likely the result of the way the device was handled when taken out of the package.However, there is not enough information provided to determine how it was handled.Therefore, a review and analysis of all available information indicated the most probable cause of the reported event is cause not established.
Event or Problem Description
It was reported to boston scientific corporation that a flexima nasobiliary catheter was to be implanted during a procedure performed on (b)(6) 2025.Prior to the procedure, it was noticed that near the pig part and the hardness change section was separated, rendering it unusable.Another flexima nasobiliary catheter was used to complete the procedure.There were no patient complications reported as a result of this event.

• Brand Name: FLEXIMA? NASOBILIARY CATHETER
• 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: 22128057
• Report Number: 3005099803-2025-02390
• Device Sequence Number: 12932466
• Product Code: FGE
• UDI-Device Identifier: 08714729337379
• UDI-Public: (01)08714729337379(17)270930(10)34956837
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K982508
• 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): 07/08/2025

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: M00540110
• Device Catalogue Number: M00540110
• Device Lot Number: 0034956837
• 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: 05/07/2025
• Supplement Date Received by Manufacturer: 06/13/2025
• Initial Report FDA Received Date: 06/02/2025
• Supplement Report FDA Received Date: 07/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/30/2024
• 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 Sex: Unknown