MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION Flexima? Nasobiliary Catheter; catheter, biliary, diagnostic

Model Number	M00540130
Medical Device Problem Codes	Break (1069); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	05/28/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Block h6: imdrf device code a0401 captures the reportable event of catheter break.Imdrf patient code e2008 captures the reportable event of unretrieved device fragment.
Event or Problem Description
It was reported to boston scientific corporation that a flexima nasobiliary catheter was intended to be implanted in the common bile duct to treat jaundice and lower abdominal pain during an endoscopic retrograde cholangiopancreatography (ercp) procedure with stone removal performed on (b)(6) 2026.During the procedure, the tip of the nasobiliary drainage catheter fractured after it had been inserted into the patient.The fractured segment remained in the patient's common bile duct and was difficult to retrieve.The procedure was completed with another of the same device.There were no patient complications reported as a results of this event and the patient's condition at the conclusion of the procedure was reported to be stable.
Event or Problem Description
It was reported to boston scientific corporation that a flexima nasobiliary catheter was intended to be implanted in the common bile duct to treat jaundice and lower abdominal pain during an endoscopic retrograde cholangiopancreatography (ercp) procedure with stone removal performed on (b)(6) 2026.During the procedure, the tip of the nasobiliary drainage catheter fractured after it had been inserted into the patient.The fractured segment remained in the patient's common bile duct and was difficult to retrieve.The procedure was completed with another of the same device.There were no patient complications reported as a results of this event and the patient's condition at the conclusion of the procedure was reported to be stable.
Additional Manufacturer Narrative
Block h6: imdrf device code a0401 captures the reportable event of catheter break.Imdrf patient code e2008 captures the reportable event of unretrieved device fragment.Block h11: investigation results: based on the information available, boston scientific could not confirm the reported event of catheter break.The complaint device was not returned; therefore, product analysis could not be performed.However, the customer provided a picture where it can be observed one of the catheter holes torn.Without proper evaluation of the device, it remains unknown the most probable causes that contributed to the events.Device history record review: 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: the complaint device was not returned; therefore, product analysis could not be performed.However, the customer provided a picture where it can be observed one of the catheter holes torn.Similar complaint review: a similar complaint review was completed.There were no emerging trends identified that warrant further action.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? 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 ; +1(914)571-6918
• MDR Report Key: 25630754
• Report Number: 3005099803-2026-02590
• Device Sequence Number: 9837183
• Product Code: FGE
• UDI-Device Identifier: 08714729337393
• UDI-Public: (01)08714729337393(17)280505(10)36448655
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K982508
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 09/29/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: M00540130
• Device Catalogue Number: M00540130
• Device Lot Number: 0036448655
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/28/2026
• Supplement Date Received by Manufacturer: 06/29/2026; 09/02/2026
• Initial Report FDA Received Date: 06/25/2026
• Supplement Report FDA Received Date: 07/21/2026; 09/29/2026
• Date Device Manufactured: 05/06/2025
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 38 YR
• Patient Sex: Female
• Patient Weight: 132 LB