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

Model Number	M00539260
Medical Device Problem Codes	Break (1069); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/08/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported to boston scientific corporation that a flexima biliary preloaded stent was to be used in the biliary tract during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2025.During the procedure, the inner sheath was fractured during the release.The procedure was completed using another of the same device.There was no patient complications reported as a result of this event and the patient's condition remained stable after the procedure.
Additional Manufacturer Narrative
Block e1: the initial reporter's facility name: (b)(6) hospital - reported here as the facility name exceeded character limit for the designated field.Block h6: imdrf device code a0401 captures the reportable event of catheter-guide break.
Event or Problem Description
It was reported to boston scientific corporation that a flexima biliary preloaded stent was to be used in the biliary tract during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2025.During the procedure, the inner sheath was fractured during the release.The procedure was completed using another of the same device.There were no known patient complications were reported as a result of this event and the patients condition remained stable after the procedure.
Additional Manufacturer Narrative
Block b5 has been corrected.Block e1: the initial reporter's facility name: (b)(6) hospital reported here as the facility name exceeded character limit for the designated field.Block h6: imdrf device code a0401 captures the reportable event of catheter-guide break.
Additional Manufacturer Narrative
Block b5 has been corrected.Block e1: the initial reporter's facility name: (b)(6).Blocks e1 (initial reported address 1 and 2) and h6 have been corrected.Block h6: imdrf device code a0401 captures the reportable event of catheter-guide break.
Event or Problem Description
It was reported to boston scientific corporation that a flexima biliary preloaded stent was to be used in the biliary tract during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2025.During the procedure, the inner sheath was fractured during the release.The procedure was completed using another of the same device.There was no patient complications reported as a result of this event and the patient's condition remained stable after the procedure.
Event or Problem Description
It was reported to boston scientific corporation that a flexima biliary preloaded stent was to be used in the biliary tract during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2025.The patient's anatomy was tight.During the procedure, the inner guide catheter was fractured during deployment.The broken guide catheter was removed from the patient using biopsy forceps.The procedure was completed using another of the same device.There was no patient complications reported as a result of this event and the patient's condition remained stable after the procedure.
Additional Manufacturer Narrative
Blocks b1, b2, b5, and h1 have been corrected.Block e1: the initial reporter's facility name: the first affiliated hospital of fujian medical university - reported here as the facility name exceeded character limit for the designated field.Block h6: imdrf device code a0401 captures the reportable event of catheter-guide break.Imdrf impact code f2301 captures the used of additional device to remove the broken guide catheter.Block h11: a flexima biliary stent and delivery system were received for analysis and the device was returned without the guide catheter, which was detached.Furthermore, it was observed that the push catheter was bent.No other problems were noted with the stent and delivery system.Product analysis confirmed the reported event of catheter guide break.It is most likely that procedural factors such as handling of the device and the technique used by the physician during the procedure likely resulted in the damages encountered.Therefore, a review and analysis of all available information indicated the most probable cause is adverse event related to procedure.

• 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: arlene acevedo gutierrez ; 300 boston scientific way; marlborough, MA 01752 ; 7877968283
• MDR Report Key: 21260242
• Report Number: 3005099803-2025-00160
• Device Sequence Number: 20846868
• Product Code: FGE
• UDI-Device Identifier: 08714729162575
• UDI-Public: (01)08714729162575(17)270430(10)33935848
• 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,Followup
• Report Date (Section B): 03/31/2025

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: M00539260
• Device Catalogue Number: M00539260
• Device Lot Number: 0033935848
• 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: 01/09/2025
• Supplement Date Received by Manufacturer: 01/28/2025; 02/09/2025; 03/27/2025
• Initial Report FDA Received Date: 01/28/2025
• Supplement Report FDA Received Date: 01/30/2025; 03/03/2025; 03/31/2025
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 48 YR
• Patient Sex: Male
• Patient Weight: 68 KG