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

Model Number	M00540120
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/21/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Imdrf device code a0401 captures the reportable event of catheter break.
Event or Problem Description
It was reported to boston scientific corporation that a flexima nasobiliary catheter was used in the gallbladder to treat a common bile duct stone during a procedure performed on (b)(6), 2025.During the procedure, the device ruptured.Another of the same device was used to complete the procedure.There were no patient complications reported as a result of this event and the patient condition after the procedure was reported to be stable.
Event or Problem Description
It was reported to boston scientific corporation that a flexima nasobiliary catheter was used in the gallbladder to treat a common bile duct stone during a procedure performed on (b)(6) 2025.During the procedure, the device ruptured.Another of the same device was used to complete the procedure.There were no patient complications reported as a result of this event and the patient condition after the procedure was reported to be stable.
Additional Manufacturer Narrative
Block h6: imdrf device code a0401 captures the reportable event of catheter break.Block h11: a nasobiliary catheter was received for analysis.Visual examination of the returned device found no damages on the catheter.No other problems were noted with the device.Product analysis did not confirm the reported event of catheter break, as no visual damage was observed on the catheter.The cause of the reported event cannot be established, as it occurred during the procedure and the device could not be properly evaluated.Therefore, a review and analysis of all available information indicated that the most probable cause is no problem detected.

• 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: christina lam ; 300 boston scientific way; marlborough, MA 01752 ; 9145716918
• MDR Report Key: 22982248
• Report Number: 3005099803-2025-04573
• Device Sequence Number: 21089508
• Product Code: FGE
• UDI-Device Identifier: 08714729337386
• UDI-Public: (01)08714729337386(17)270227(10)33522637
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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): 11/14/2025

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: M00540120
• Device Catalogue Number: M00540120
• Device Lot Number: 0033522637
• 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: 08/21/2025
• Supplement Date Received by Manufacturer: 10/22/2025
• Initial Report FDA Received Date: 09/05/2025
• Supplement Report FDA Received Date: 11/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/28/2024
• 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: 56 YR
• Patient Sex: Female
• Patient Weight: 66 KG