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

Model Number	M001274030
Medical Device Problem Codes	Difficult to Advance (2920); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/18/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluated by mfr: the flexima device was returned to our post market quality assurance laboratory.A visual inspection was performed and identified that the stent does not have any visual damage and both pigtails returned in good condition.However, the suture returned cut.A 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
Reportable based on device analysis completed on 24nov2025.The target lesion was located in the kidney to the bladder.A flexima was selected for use.During the procedure, a hard resistance was felt when the catheter was pushed.The procedure was completed with another of the same device.There were no patient complications as a result of this event.However, device analysis revealed the suture returned cut.

• 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: 23843477
• Report Number: 2124215-2025-91840
• Device Sequence Number: 9958503
• Product Code: FAD
• UDI-Device Identifier: 08714729323785
• UDI-Public: (01)08714729323785(17)280330(10)36192072
• 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
• Report Date (Section B): 12/18/2025

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: M001274030
• Device Catalogue Number: M001274030
• Device Lot Number: 0036192072
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/24/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/24/2025
• Initial Report FDA Received Date: 12/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/31/2025
• 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: Female