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

Model Number	M001271860
Medical Device Problem Codes	Deformation Due to Compressive Stress (2889); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/26/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Reportable based on device analysis completed on 17sep2025.It was reported that the sheath buckled.A vtc/8/k flexima regular was selected for a nephrostomy procedure.During preparation, the 0.018 wire snagged within the three-part needle sheath and caused damage to the device itself.The vtc/8/k flexima regular was not used to complete the procedure.There were no patient complications as a result of this event.However, device analysis revealed that the radiopaque marker was torn at the middle to tip section of the sheath.
Additional Manufacturer Narrative
E1: initial reporter phone: +(b)(6).Device evaluation by manufacturer: unit returned and device was inspected.It was observed that the radiopaque marker was returned for analysis, however the stent was not returned.It was possible to observe that the radiopaque marker was torn at the middle until the tip section.Under microscope magnification the radiopaque marker was torn at the middle until the tip section.

• 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: 23302274
• Report Number: 2124215-2025-72054
• Device Sequence Number: 20049503
• Product Code: GBO
• UDI-Device Identifier: 08714729323372
• UDI-Public: (01)08714729323372(17)280312(10)36061358
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/15/2025

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: M001271860
• Device Catalogue Number: M001271860
• Device Lot Number: 0036061358
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/24/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/17/2025
• Initial Report FDA Received Date: 10/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/13/2025
• 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
• Patient Sex: Unknown