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

Model Number	M001274180
Medical Device Problem Code	Difficult to Insert (1316)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/19/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the procedure was cancelled.This flexima? drainage catheter system kit was selected for a ureteral stent injection procedure.During the procedure, the dual layer portion of the distal tip was not inserted into the 8fr sheath.The procedure was not completed due to this event.There were no patient complications as a result of this event.
Additional Manufacturer Narrative
B5.Describe event or problem: added information, based on additional information c2/d10 - concomitant product/therapy: updated.
Event or Problem Description
It was reported that the procedure was cancelled.This flexima? drainage catheter system kit was selected for a ureteral stent injection procedure.During the procedure, the dual layer portion of the distal tip was not inserted into the 8fr sheath.The procedure was not completed due to this event.There were no patient complications as a result of this event.It was further reported that the distal layer portion could not be advanced into the 8fr sheath.The physicians had to cut off the problematic section with scissors before completing the procedure.
Additional Manufacturer Narrative
Device evaluated by mfr: the ureteral stent device was returned to our post market quality assurance laboratory.Media inspection identified that the picture attached showed what seems to be part of the stabilizer, however, the reported allegation is not clearly seen with the evidence provided.Visual inspection identified that the stent does not have any visual damage and both pigtails returned in good condition.The cannula did not return for analysis.Functional inspection was performed and a mandrel of 0.039 in was inserted in the stent to extend the pigtails and the mandrel passes smoothly.Also, the drainage holes do not look obstructed.In general, no issues were found on the device.This concludes the product analysis.
Event or Problem Description
It was reported that the procedure was cancelled.This flexima? drainage catheter system kit was selected for a ureteral stent injection procedure.During the procedure, the dual layer portion of the distal tip was not inserted into the 8fr sheath.The procedure was not completed due to this event.There were no patient complications as a result of this event.It was further reported that the distal layer portion could not be advanced into the 8fr sheath.The physicians had to cut off the problematic section with scissors before completing the procedure.

• 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: 23807110
• Report Number: 2124215-2025-90898
• Device Sequence Number: 7708072
• Product Code: FAD
• UDI-Device Identifier: 08714729323921
• UDI-Public: (01)08714729323921(17)280523(10)36601566
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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,Followup
• Report Date (Section B): 02/19/2026

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: M001274180
• Device Catalogue Number: M001274180
• Device Lot Number: 0036601566
• 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: 11/20/2025
• Supplement Date Received by Manufacturer: 11/25/2025; 01/21/2026
• Initial Report FDA Received Date: 12/15/2025
• Supplement Report FDA Received Date: 12/22/2025; 02/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/24/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SHEATH - 8FR MERIT PRELUDE; SHEATH - 8FR MERIT PRELUDE
• Patient Age: 59 YR
• Patient Sex: Male