MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION FLEXIMA; TUBE, DRAINAGE, SUPRAPUBIC

Model Number	32095
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	10/15/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that catheter fracture occurred.The target lesion was located in the liver.A flexima drainage catheter was selected for use in a percutaneous transhepatic biliary stenting (ptbs) and percutaneous transhepatic cholangiodrainage (ptcd) procedure.During preparation, it was found that the catheter was fractured and it could not be used.The procedure was completed with another of the same device.There was no patient injury as a result of this event.
Additional Manufacturer Narrative
E1: initial reporter facility name: (b)(6).
Event or Problem Description
It was reported that catheter fracture occurred.The target lesion was located in the liver.A flexima drainage catheter was selected for use in a percutaneous transhepatic biliary stenting (ptbs) and percutaneous transhepatic cholangiodrainage (ptcd) procedure.During preparation, it was found that the catheter was fractured and it could not be used.The procedure was completed with another of the same device.There was no patient injury as a result of this event.
Additional Manufacturer Narrative
(b)(6).Device evaluated by mfr: the complaint device was returned to our post market quality assurance laboratory.The device returned with the needle, the 8f dilator, the guidewire, the flexible cannula and the tube connector.These components return in good condition.The metal cannula returned assembled in the catheter; however, it is kinked.There is no evidence of a detachment in the catheter, but the luer lock male from the metal cannula is detached that could be related to what the customer reports by "the catheter was fractured".There is evidence of loctite in the cannula indicating the male adaptor was attached initially.The metal cannula was removed from the catheter, and no resistance was felt when removing the cannula, and the pig tail does form correctly.

• Brand Name: FLEXIMA
• Common Device Name: TUBE, DRAINAGE, SUPRAPUBIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 2546 calle primera; alajuela ; CS
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 23543427
• Report Number: 2124215-2025-80750
• Device Sequence Number: 18585894
• Product Code: FGE
• UDI-Device Identifier: 08714729323273
• UDI-Public: (01)08714729323273(17)270226(10)35278565
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K944290
• 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): 12/23/2025

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: 32095
• Device Catalogue Number: 32095
• Device Lot Number: 0035278565
• 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: 10/17/2025
• Supplement Date Received by Manufacturer: 12/01/2025
• Initial Report FDA Received Date: 11/13/2025
• Supplement Report FDA Received Date: 12/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/27/2024
• 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: 52 YR
• Patient Sex: Male
• Patient Weight: 60 KG